Monday, September 29, 2008


To provide procedure for Calibration of High Pressure Liquid Chromatography.
2.0. SCOPE:
Applicable to HPLC
Make : Shimadzu
Model : LC-2010AHT
Pump : LC-10Atvp Detector : SPD-10Avp
System Controller : SCL-10Avp
Auto Injector : SIL-10Advp
3.1. Officer -QC
3.2. Executive-QC
Manager-Quality Control
6.1. Start the HPLC pump as per IOP and check the flow rate by collecting water in a 10ml measuring cylinder. Using a stop watch set the time for 5 minutes and measure the volume collected for 1.0ml/ minute 1.5ml/minute and 2.0ml/minute flow rates respectively. Note the readings in duplicates.
Time in minute 5min
Flow rate 1ml/min
Volume of water collected in ml Pump A: ____ Pump B: _____
Limit in ml 4.95-5.05
Time in minute 5min
Flow rate 1.5ml/min
Volume of water collected in ml Pump A: ____ Pump B: _____
Limit in ml 7.45-7.55
Time in minute 5min
Flow rate 2ml/min
Volume of water collected in ml Pump A: ____ Pump B: _____
Limit in ml 9.95-10.056.2.

Chromatographic system:
Column : C18 Or C 8 (25cmx 4.0mm), (5micron
Column No. to be mentioned in reports.
Detector : 254nm
Flow rate : 1ml/min
Mobile phase : Degassed and filtered solution containing
Acetonitrile : Water ( 70 : 30 )
Injection volume : 20 ml.
Standard preparation : Transfer 1ml of Toluene and 1ml of Benzene into a 100ml volumetric flask and make upto volume with methanol, shake well, further dilute 5ml to 50ml with methanol. Inject 20ml of standard solution for five times.
Record the following
1. RT of Toluene and Benzene : RSD NMT 2.0%
2. Area of Toluene and Benzene : RSD NMT 2.0%
3. Theoretical plates of Toluene and Benzene : NLT 1500
4. Resolution between Toluene and Benzene : NLT 2.0
To a clean, dry 100ml volumetric flask, add 0.1ml of Benzene and 0.1ml of Toluene. Mix by adding mobile phase and make up to volume. Inject equal quantities three times and record the ratio of the peak area.
Chromatographic conditions
Detector : 254nm
Flow Rate : 1.0 ml/minute
Mobile Phase : Methanol : Water = 80 : 20
Absorbance Scale : 0.02
Attenuation : 5
Injection Volume : 20ml
Column : C-18 (Shim-pak)
Area of first peak
Area of second peak
Injection No. Ratio % deviation from the average (limit±2%)

Dedicated columns are used as mentioned in the monograph.
FREQUENCY OF CALIBRATION: Once in three months
Instrument Manual


To provide a procedure for calibration of balance.
2.0 SCOPE:
This covers the calibration procedure for balance. (Instrument No:QC-001)
3.1 Chemist-QC
3.2 Officer-QC
6.1.1. Ensure that balance is aligned properly and cleaned i.e. the spirit level should be in the center of the circle.
6.1.3 Ensure that the display shows 0.00000
Place 4 standard weights of different denominations as per the schedule & record the weight.
6.1.4 The observed weight should confirm with the acceptance criteria as given in the balance log sheet.
6.1.5 If the instrument goes out of calibration contact the service person for necessary adjustment and recalibrate.
Instrument Manual
Enclosed a table for Acceptance Criteria for Standard Weights, Calibration report format & Calibration schedule.


To ensure correct method of operation for balance.
2.0 SCOPE:
It covers the procedure for operation of balance
6.1 Make sure that the balance is kept clean.
6.2 Ensure that the calibration status is valid.
6.3 Ensure that spirit level is in the center of the circle.
6.4 Connect the power cable to the mains and switch ‘ON’.
6.5 Automatically self checking starts from “che-3” & ends with OFF.
6.6 Press ON/OFF key, all the display will glow.
6.7 Press “TARE KEY ”, 0.00000 mark appears on the display.
6.8 The stability of the reading is obtained which is indicated by an arrow mark on the left side of the display.
6.9 Once the stability is attained, the balance is ready for weighing.
6.10 Place the material to be weighed on the pan & note down the reading after the arrow mark appears on the left side of the display.
6.11 After completion of weighing press, “ON/OFF” key. “ STAND BY” light glows.
6.12 Clean the balance immediately after weighing.
6.13.1 Do not weigh on the pan directly. Always use butter paper.
6.13.2 Do not place heavy glassware on the pan. It may damage the instrument
6.13.3 Do not weigh corrosive acids & hot materials.
6.13.4 Do not shift the balance once positioned
6.13.5 Do not give shock to pan or table.
6.13.6 Close the glass doors on the sides and top before recording the weights
6.13.7 Handle the balance gently and carefully.
6.13.8 Do not press the material on the pan with spatula
6.13.9 Do not spill any material during weighing.
6.13.10 Do not use butter paper size more than the area of pan
6.13.11 Dry the silica gel for every week.
6.13.12 After completion of weighing keep the inside area clean .
Instrument Manual
1. Always keep the balance in “ STAND BY” position when not in use.
2. Note down the reading only after obtaining stability indicated by an arrow mark at the left side of the display board.


To detailed the procedure for the operation of Distilled water unit.
2.0. SCOPE:
Applicable to distilled water unit.
QC Executive
6.1. Ensure the electrical connections are proper.
6.2. Ensure the water circulation is continuous.
6.3. Check for the water level in the heater tank.
6.4. Switch on the instrument.
6.5. Place a clean plastic container meant for distilled water collection at the outlet of the
distillation unit and collect the distilled water in it.
6.6. Discard the first 200ml of water and collect the distilled water for lab use.
6.7.Check the clarity visually, if clear, carryout conductivity & chloride test .Conductivity
NMT 4.0 m s cm-1 , chloride should be nil. Then use it for regular analysis.
6.8. Instrument when not in use switch off the instrument first and then stop the water connection.
Never switch on the equipment without continuous water circulation.

Friday, September 26, 2008


To provide a procedure for change in specification of raw materials.
2.0 SCOPE :
Applicable to purchase, stores and QC/QA Department
It is the responsibility of QC/QA Department/ personnel to assure the right material is used in the formulations.
4.1 As per the requirement of the product , the specified raw material with specification shall be ordered to the manufacturer/supplier.
The manufacturer/supplier will supply the material to the manufacturing site with DC/Invoice
4.2 The store Department prepares the GRN and sends to Q.C. for sampling, testing and release
4.3 Q.C. carries out sampling as per the sampling procedure, tests and approves/rejects the material and GRN shall be passed.
4.4 In case of change in specification the material shall be tested as per the required specification. After testing, passed material shall be dispensed and used. The copy of the test certificate shall be available in stores.


This procedure describes the method of disposal of expired Finished products/Raw materials.
2.0 SCOPE :
Applicable to all Finished products/Raw materials
Quality Control personnel
4.1 After the expiry of Raw Materials/Finished Products collect all the samples and store separately
4.2 Retain all the expired products for one year after the expiry for destruction.
4.3 The details of expired products waiting for destruction should be entered in the register
4.4 Once in a month, the concerned QC personnel check the expiry of the product.
4.5 Tablets are removed from the bulk containers/strips/ blisters and disposed in a container and destroyed by adding water.
4.6 All the liquid bottles are opened and emptied into the waste disposal
4.7 Empty bottles and caps are crushed and sent to scrap yard
4.8 All expired raw materials are disposed in a container containing water


To illustrate the procedure for non moving & expired chemicals.
2.0 SCOPE :
It covers all lab chemicals.
Q.C. chemist.
4.1 The label on the container of the chemical should have date of receipt and validity period
4.2 If the chemical is expired and those items which are not being used for longer time and contaminated chemicals are subjected to disposal.
4.3 The person who disposes the chemical should wear mask, gloves & safety goggles
4.4 The chemical to be disposed is put in a bucket containing water, dissolved and drain into ETP plant.
4.5 After disposal the container is crushed and subjected to scrap.
4.6 Maintain a log book containing chemical no, chemical name, date of disposure, disposed by and checked by etc.

Instrument change control SOP

To provide a procedure for use of the equipment and instrument after replacing spares or repair.
2.0. SCOPE :
It covers the procedure for use of the equipment and instrument after replacing spares or repair.
QC Personnel.
Whenever equipment is repaired or spare part is replaced. it should be calibrated before being put into use for routine work. Following steps to be taken in regards to the qualification of the said equipments
6.1. Equipment spare should be correct and as per the specification given in the manual.
6.2. It should be properly installed.
6.3. Calibrate the instrument, it has to comply as per calibration SOP.
6.4. A standard sample previously analysed should be subjected for analysis on the instrument which is being installed.
6.5. Data of analysis of the samples minimum three readings should be compared with old data of the same sample.
6.6. When both the datas are comparable it can be concluded that the instrument can be used for regular analysis.


This Procedure defines the method of sampling, testing/approval/ non-conformity of intermediates/finished products.
2.0 SCOPE :
Applicable to all In process, and Finished Products.
Quality Control & Quality Assurance Personnel.
4.1 The production department shall send TI/TRF for sampling giving details like Product, Batch No, Batch size, Mfg date and Exp date.
4.2 On receipt of the TI/ TRF, along with sample QC officers shall arrange for Analysis.
4.3 On receipt of the sample, it shall be taken for analysis as per the specification
4.4 The test report shall be prepared by the Chemist, checked by QC Executive/Asst. Manager for approval or non conformance and finally approved by Q.C. Manager.
4.5 In case of finished product, after completion of packing QA chemist shall collect samples of finished pack along with PRRF raised by packing department, which will be submitted to Q.C. for analysis.
4.6 All Approved intermediates and Bulk (TI/TRF) / finished product reports (PRRF) shall be stamped as “PASSED”.
4.7 All non conforming intermediates and Bulk shall be stamped as QUARANTINE and shall be informed to the Q.C. Manager.


To provide a procedure for sampling of packing material.
2.0. SCOPE:
Applicable to all Packing material.
Quality control Chemist
Quality Control-Manager
Sampling: It is a process of collecting the materials so that the collection shall represent the whole batch of the consignment.
Consignment: It is a supply of a material of particular batch intended to be used in different department.
Lot: A defined quantity of material made by a specified process cycle having uniform quality.
6.1. Sampling personnel
Sampling shall be carried out by trained personnel who are observant and meticulous.
6.2.1. All the packages shall be sampled if the lot contains not more than five
Containers / packets. If the lot contains 5 to 24 packages, 5 packages shall be
sampled. If the lot contains 25 and above packages Ön+1 containers shall be
sampled where 'n' is the total number of package in the consignment
6.2.2. A two-stage sampling plan shall be followed. The quantities of units to be
drawn from the number of packages selected in Step 6.2 are detailed in step 6.3 At
the first stage of sampling a sufficiently large quantity shall be removed in order to
carryout a visual examination of all the units sampled.
Defects as detailed in step 6.3. shall be looked for.
6.2.3. If these defects appear to be excessive the matter shall be reported to the
Senior Quality Assurance Manager, who shall decide whether or not sampling at the
second stage shall be done. The quantities drawn at stage 1 shall be added back to
the lot, if the results of visual observation are satisfactory.
It should be in accordance to the type of Packing Material .
6.2.4. On receipt of TRF from stores ,QC Chemist shall makes the entry in Packing Material inward register and arranges for sampling.
6.2.5. QC Chemist checks the consignment by comparing the details of TRF with status board prepared by stores.
6.3. Depending on the type of the material, the sampling is carried out as follows
6.3.1. Quantity of sample to be drawn : Outer Cartons
About 4 to 5 bundles shall be drawn from each package selected in step 6.2,
and observed for,
a)Code No.
c)Cutting and Creasing
d)Self-lock bottom pasting.
e)Ghost image.
f)Colour variation.
g)Missing copy matter etc.
h)Mix-up with the cartons of another product/s.
Cartons shall be drawn from all the selected packages for complete analysis. Label :
4 to 5 bundles shall be drawn at random from each package selected in step 6.2 and observed for
a)Code No.
b)Ghost image
c)Colour variation
d) Missing copy matter
e) Label cutting etc.
f) Mix-up with the labels of another product/s
About 10 Labels shall be drawn at random from all selected packages and subjected to complete analysis. Catch-Covers :
About 4 to 5 bundles shall be drawn at random from each package selected in step 6.2 and observed for
a) Code No.
b. Ghost image
c. Colour variation
d. Missing copy matter
e. Pasting of pouches etc.
f. Mix-up with the catch-covers of another product/s
10 catch-covers shall be drawn at random from all the selected packages and subjected to complete analysis. Master Cartons, Outer Boxes :
10 numbers shall be drawn from the number selected as per step 6.2 at random, and observed for
a. Code No.
b. Variations in dimensi
c. Cutting
d. Creasing and pasting
e. Number of ply
f. Rupture of material when the flap is bent back by 180o C
One sample shall be drawn and subjected to complete analysis Plates and Partitions :
10 numbers shall be drawn from the number selected as per step 6.2 at random and observed for,
a. Variations in dimensions
b. Proper fixing of cells in partitions
c. One number shall be drawn at random from all the selected packages and subjected to complete analysis. Blister Foil :
About 10 to 15 meters of foil shall be drawn from each package selected in step 6.2 and observed for,
a. Clarity of printing and peel test in case of printed foil.
b. Pin holes.
c. Continuation of coating on the sealing side of the foil
d. Winding of reels, variation in the foil width, copy matter shifting etc.,
e.Reel outer diameter and inner core diameter Strip Foil :
About 10 to 15 meters of foil shall be drawn from package selected in step 6.2 and observed for
a. Code No.
b. Clarity, missing of printing and peel test in case of printed foil.
c. Pin holes
d. Continuity of polythene laminate.
e. Winding of reels, variation in the foil width, shifting of the copy matter.
f. Reel outer diameter and inner core diameter.
About one foot shall be drawn from all the selected packages and subjected to complete analysis P.V.C. Film :
About 10 to 15 meters of PVC film shall be drawn
from each package selected in step 6.2 and observed for
a. Pin holes
b. Uniformity of Thickness
c. Winding of reels, variation in the film width etc.
d. Reel outer diameter and inner core diameter.
About one foot shall be drawn from all the selected packages and
subjected to complete analysis. Glass Bottles :
All the selected number of packages as per step 5.2 shall be opened and observed for
a. Molding defects
b. Air bubbles, seeds, and foreign matters.
c. About 10 bottles shall be drawn at random from all the selected packages for complete analysis. Plastic Containers :
5 numbers shall be drawn from each package selected in step 6.2 and observed for.
a. Molding defects
b. Foreign matters
5 containers shall be drawn at random from all the selected packages for complete analysis. Metal Containers :
5 numbers shall be drawn from each package selected in step 6.2 and
observed for
a. Proper sealing
b. Proper diaphragm
c. Proper closing of lids
5 containers shall be drawn at random from all the selected packages
for complete analysis
Labeling Paste:
About 100-g shall be drawn from the number selected as per step 6.2 and observed for
a. Foreign matters Bopp Tapes :
Tapes shall be drawn at random from each package selected in step 6.2 and observed for
a. Winding of roll
b. Outer dia. of roll and inner core dia
5 rolls shall be drawn and subjected to complete analysis. Heat Sealing Straps :
About 15 to 20 meters of straps shall be drawn from each package selected in step 5.2 and observed for
a. Clarity of printing
About 10 meters shall be drawn from all the selected packages
and subjected to complete analysis. P. O. P. P. Caps :
10 numbers of caps shall be drawn from each package selected in step 6.2 and observed for
a.Mottling of printing and discolouration
b. Uneven cutting or tool marks
c. Foreign matters
d. Proper decoration / Embossing
About 10 numbers at random shall be drawn from all the selected packages and subject for complete analysis. Aluminum Collapsible Tubes :
10 numbers of tubes shall be drawn from each package selected in
step 6.2 and observed for
a. Code No.
b. Sharpness, Ghost images and missing prints
c. Colour shade variation
d. Tight fitting of the cap
e. Free from dusts and foreign particles.
f. Mix-up with the tubes of another product/s.
About 10 numbers at random shall be drawn from all the selected packages and subjected to complete analysis
6.4. Sampling Procedure:
6.4.1. Details shall be verified from the packages against the details given in
the Test Request Form for
a. Name of the material.
b. G. I. Number.
c. Name of the supplier.
d. Quantity stated on the Label.
e. Quantity received.
f.Total number of packages.
6.4.2. General condition of the package shall be checked.
6.4.3. Required number of samples shall be drawn as per the sampling plan. Th sample drawn at first stage shall be subjected to visual examination and the observations recorded on the respective results of Analysis Sheet. At the second stage sample shall be drawn for complete analysis.
6.4.4. Sufficient no. of "UNDER TEST" labels shall be affixed on all the containers of the bottom most row of Packing Material supplies. Sampled seal shall be affixed on the 'Under Test' labels signifying that the lot is sampled. In addition, depending on the number of packages supplied, a hand-written Status Board shall be attached on the Pallet of the material. The Status Board shall also indicate the total number of packages in the consignment
6.5. Sampling Precautions
6.5.1. Packages shall be resealed immediately after sampling
6.5.2. Mix-up of lots shall be avoided during sampling.
Test Request Form
Under Test Label Format
Status Board
TRF: Indicates Test Request Form.
PM Inward Register: Indicates Raw Material Inward Register
A.R.No: Indicates Analytical Reference No

Raw Material Sampling SOP

To detail the procedure for sampling.
2.0 SCOPE :
Applicable during sampling of all Raw material active ingredients and Inactive ingredients.
All Q.C. Chemists / Officers
4.1.1 : Active & Inactive materials should be sampled from all the containers.
4.1.2 : Sugar is sampled by using squre root of n +1 formula where “n” is the number of the containers.
4.1.3 : The total quantity of material to be sampled is listed in attached index, which includes quantity required for analysis, and quantity required to be kept as control sample and microbiological analysis.
4.2.1 On receipt of GRN from stores, enter the details of the GRN into raw material inward register and allot the analytical reference No. (A.R.N o)
4.2.2 Check the GRN of the material to be sampled and if any entry is missing in GRN, get it rectified by stores personnel.
4.2.3 Record the observations on the sampling checklist.
4.2.4 Prepare and print “UNDER TEST” labels with relevant details quantity equivalent to the number of containers stated in the GRN and two additional labels for affixing on the status card and for retain sample identification bag.
4.2.5 Arrange for the required quantity of self-sealing polythene bags.
4.2.6 Check the sampling thief for cleanliness.
4.2.7 Arrange for safety apparels, which are required during sampling of material.
4.2.8 Check for the cleanliness of the sampling kit. If not clean, clean it with dry cloth and place “UNDER TEST” labels, self sealing polythene bags, safety apparels, GRN and check list in it.
4.2.9 Calculate the quantity of material required to be sampled from each containers.
Eg. Material à Aerosil BP
Total Qty required to be sampled (as per the attached index) is 30g, No of containers entered on GRN - 8
Qty to be drawn from the each container = Total Qty required /No. of containers = 30/8 = 4 g.
4.2.10 Sample a minimum of 2 g from each container if the qty to be drawn from each container is less than 2 g.
4.2.11 Carry the sampling bag and sampling thief to the stored quarantine area.
4.3.1 Check and ensure that sampling booth is clean.
4.3.2 Operate sampling booth, follow relevant SOP.
4.3.3 Check for the pressure differential of the booth. Ensure the pressure differential is within the set limits.
4.3.4 Check for the calibration of the balance.
4.3.5 Check for the consignment details as given in the checklist and record.
4.3.6 Check the cleanliness of the container if found satisfactory, bring all the containers of the identified batch near the sampling booth.
4.3.7 Take one container at a time into the sampling booth and check for the following on the container label.
a. Name of the material
b. Pharmacopoeia Grade
c. Batch no
d. Date of mfg. / date of expiry
e. Manufacturer.
4.3.8 After ensuring the correctness of the supplier label with the GRN, open the container.
4.3.9 Check the physical appearance of the material . If black particles / foreign particle are present, note it down on the check list.
4.3.10 Seal the polythene bag immediately after sampling.
4.3.11 Reseal the material and close the container. If poly bag /paper bag are pierced for sampling purpose, the pierced portion should be covered with LDPE sheets (10 X 10 cm) & pasted outside with Bopp tape.
4.3.12 Affix “UNDER TEST” label on the container. The label should be pasted on the right side of the manufacturer label.
4.3.13 Shift the container outside and bring another container into the sampling booth
4.3.14 Follow step 4.3.7 to 4.3.13 for all the containers.
Incase of some raw materials prone to have microbiological tests, samples are drawn asceptically. For sampling sterilised bottles, scoop, nose mask and hand gloves are used.
4.3.15 After all the containers are sampled, shift the containers back to quarantine area and affix “ UNDER TEST” label on status card, sampled bag, and microbiology sample if any..
4.3.16 Put “OFF” the airflow and power switch.
4.3.17 Enter the details in the sampling log.
4.3.18 Inform stores personnel to get the area cleaned and to make entries in the log book after cleaning.
4.3.19 For liquids/solvents use liquid sampler .Sample all the containers in to a clean dry bottles. Incase of microbiology use sterilised bottles.
4.3.20 Place the sampling thief back into the polythene cover. Place all the sampled materials and checklist into the sampling kit and bring it back to Q.C.
4.3.21 Send the sampling thief for washing
4.3.22 Enclose the sampled materials into another dry polythene bag.
4.3.23 Attach the check list to the GRN and stamp the GRN with “ SAMPLED” seal with sign and date.


This defines the procedure for testing, Approval & Rejection of all Raw material in Q.C.

2.0 SCOPE :
It covers testing & approval/rejection of all Raw materials.

Applicable to all Quality control & Quality assurance staff

4.1 On receipt of sampled raw materials, required quantity shall be taken for analysis as per the respective specification. Remaining quantity is stored as Control Sample.
4.2 Identification test should be carried out for all the individual containers sampled ( for Actives).
4.3 Batch wise analysis shall be carried out as per specification on the pooled sample for the remaining tests (Actives as well as Excipients).
4.4 All raw materials are tested as per the Raw material specification.
4.5 After analysis reports shall be prepared by Chemists. Checked by
Asst. Manager/Executives, approved / rejected as per the results, by Manager - Q.C
4.6 The GRNs shall be approved / rejected by stamping with “PASSED”
or “REJECTED" seal
4.7 The approved GRNs shall be sent to stores.
4.8 Based on the results, Q.C chemist shall affix the green APPROVED”
or a red “ REJECTED” Label on the containers.
4.9 The number of APPROVED/REJECTED label should be quantity equivalent to the No. of containers stated in the GRN and one additional label for affixing on the status card.note: “Approved” label for R.M. should have “USE BEFORE DATE” which indicates time frame with in which when the material is used, the finished product will have 100% shelf life. When material used after “USE BEFORE DATE” the shelf life of finished product need to be calculated and reduced accordingly.
4.10 In case any material is rejected for not complying with the standard specification the goods receiving note shall be sealed as ‘REJECTED’ and copies shall be forwarded to stores and purchase department.
4.11 The GRN copy shall accompany with an intimation letter duly authorised by QC Manager and QA Manager. A copy of intimation letter shall be given to Quality Assurance.
4.12 Purchase shall in turn intimate the vendor asking for investigation and CAP and a copy of the correspondence to the vendor shall be forwarded to the Quality Control Department.
4.13 A copy of investigation and CAP received by purchase department from the supplier shall be forwarded to Q.C.
4.14 The rejection material document shall be compiled with raw material report, copy of intimation to purchase, copy of correspondence from purchase to the vendor and investigation report along with corrective action plan from the vendor.

Thursday, September 25, 2008


To provide a procedure for Preparation and Authorisation of specifications.
2.0 SCOPE:
To make available specifications for RM / PM / Inprocess and Finished Products
Executive-Quality Control
Manager- Quality Control
5.1. Specification is a authorised document describing the statutory requirements are prepared with reference of Pharmacopoeias or In-house parameters.
5.2. Release Specification: A document describing in detail In-house requirements( which have requirements additional to statutory requirements and limits of certain quality parameters more stringent than the statutory limits) with which the Intermediate product and finished product has to comply.
6.1. There should be an authorised and dated specifications for raw materials and packing materials, intermediate, bulk and finished products
6.2. Specifications should be based on IP, BP, USP or In-house methods
6.3. Specifications are made based on availability of equipments, shop floor trials of PM, Stability studies of Raw materials and Finished products.
6.4. Specifications are developed and its master copy maintained by QA.
6.5. Specifications for raw materials and packing materials
6.5.1. A description of the materials including designated name and the internal code reference, and specimen of printed materials.
6.5.2. Qualitative and Quantitative requirements with acceptance limits
6.6. Specifications for Intermediate and bulk product
6.6.1. Specifications for Intermediate and bulk products should be prepared by identifying the critical parameters required for approval of further processing
6.7. Specification for finished products
6.7.1 Designated name of the product and code reference if applicable
6.7.2. The formula or reference to.
6.7.3. A description of Pharmaceutical form and package details
6.7.4. The qualitative and quantitative requirements with the acceptance limits.
6.7.5. The shelf life
7.2. SOP:QCGN:xxx
QA-Quality Assurance


To provide a procedure for Preparation and Authorisation of Test Procedures

2.0. SCOPE:
To make available specifications for RM / PM / Inprocess and Finished Products

Quality control Chemist

Manager- Quality Control

Standard test procedures are prepared for various General analytical test which includes Qualitative and Quantitative analysis.


6.1. There should be an authorised and dated Standard Test Procedures for all raw materials and packing materials, intermediate, bulk and finished products.

6.2. STP should be based on IP, BP, USP or In-house methods.

6.3. STPs are made based on Pharmacopoes, manuals and other Reference books.

6.4. Standard Test Procedures are developed and approved by Manager-QA, Authorised by Manager –QC.



STP-Standard Test Procedure


To provide a procedure for Qualification Protocol for QC Instruments.

2.0. SCOPE :
The procedure covers all the instruments used in the quality control department.

Executive-Quality Control

Manager-Quality Control



6.1. Protocol on validation should be prepared for installation of any new equipment or instrument.

6.2. Protocol should describe the following points

6.2.1. Name of the instrument

6.2.2. Code No. of the instrument

6.2.3. Instrument manufactured by/ supplied by.
a) Catalogue No.
b) Serial No.
c) Size of instrument( Height x Length x breadth)
d) Supply of power by AC/DC

6.2.4. Validation/Calibration required

6.2.5. Frequency of Validation/ Calibration.

6.2.6. Installation and Validation report

6.3. Instruments must be validated depending on its purpose and use.

6.4. Protocol will give information for preventive maintenance.

6.5. It should be documented in case of deviation or modification made to the instrument

Instrument Manual, SOP:QCGN:xxx




To provide a procedure for the action to be taken in the event of out of Calibration of instruments.

2.0. SCOPE:
Applicable to all the QC instruments


3.1. Quality Control Chemist

3.2. Maintenance Engineer

Manager-Quality Control


Following actions should be taken in the event of out of calibration status of instruments.

6.1. Inform the head of the QC department and affix a status label 'OUT OF CALIBRATION'

6.2. Inform the Maintenance department to carry out in house rectification of the instrument.

6.3. If the in-house maintenance department can rectify the defect, then use the instrument after proper calibration.

6.4. In case in-house maintenance department is unable to rectify the defect, call the supplier / manufacturer of the instrument.

6.5. Once the said instrument is repaired then carry out calibration and ensure that it is working satisfactorily.

6.6. If the external expert performs the servicing satisfactorily, use the instrument after calibration for routine analysis.

6.7. If the external expert fails to rectify the instrument, Affix a status label ' OUT OF ORDER'

6.8. Arrange to replace the instrument
In case an instrument is found out of calibration then the results of previous calibration are reviewed.





To provide a procedure for Stability study.

1.1. To gain a thorough understanding of any chemical and physical changes and
microbiological changes to which the formulations may be exposed during the
shelf life under different storage conditions.

1.2. To confirm that our formulations are stable and satisfactory in marketed pack through out the cycle of ware housing distribution , storage and use.

1.3. To recommend storage conditions, retest periods and shelf life.

1.4. To monitor any impact of changes in manufacturing process and its impact on product
quality on long term storage .

2.0. SCOPE:
To assign responsibility for the preparation & control of Batch record.

Quality Control Chemist

4.0. Accountability:
Manager -QC

5.0. Definition:

6.1. Stability study sample to be kept in marketed pack or similar to the marketed pack. e.g. Blister pack and Bulk pack.

6.2. If a product is more than one pack , stability studies should be carried out on
each of the packs.

6.3. Quantity of the sample should be sufficient for 12 individual analysis on the test selected .

6.4. Container / closure evaluation should be for in-process, storage transportation of products, compatibility with packaging materials, moisture permeation , light exposure and closure sealability .

6.5. Selection of batches and storage condition for stability studies

6.6. First three trial or pilot batches at accelerated temperature and humidity say 40 ° C/ 75% RH at 4,8,12 and 26 weeks.

6.7. First three production batches at long term stability . 4,8,12,26,52,78,104,130,156 weeks at 25°C/ 60% RH

6.8. RT : 8,12,26, 52,78,104,130,156 weeks
6.8.1. 30°C /60% RH
6.8.2. 37 ° C : 4,8,12,26 weeks
6.8.3. 45 ° C : 4,8,12 weeks

6.9. One regular production batch every year for long term stability study i.e, 25°C /60%RH, 30°C /60% RH, RT , 37°C .

6.10. Batch in which there is a change in process or container, closure/ of primary packing or RM sources for accelerated stability evaluation i.e, 40°C /75%RH , RT , 37°C.

6.11. Selection of parameter for evaluation

a) Chemical stability.
b) Physical stability.
c) Micro biological stability.

6.12. Stability testing protocols.: Protocols should describe the details

6.12.1. Description of pack .

6.12.2 Frequency of testing

6.12.3. Storage conditions.

6.12.4. Assessment of results

6.13. Assessment and submission of stability study data

6.13.1. Review of results at each interval to see if there are significant changes / variation of results by more than 5% of the initial value

6.13.2. Suggestion of changes / improvement based on stability strength.

6.13.3. Annual summary of the batches under stability .

6.13.4. Revision in storage condition of the product based on the results

6.13.5. Recommendations for the change in pack based on the results.


To lay down guidelines for training of new entrants and periodic retraining of technical staff.

2.0. SCOPE:
To define role/responsibility of various functions responsible for technical training.


3.1. Corporate Managers

3.2. Departmental Manager(Qualified Trainer

3.1 Overall responsibility to assess the training needs and ensure that training is conducted as per the annual schedule with QA.

3.2 Unit QA Manager shall give cGMP training with help from Corporate QA.

3.3 The Unit QC manager with the help of Corporate manager Quality Control shall give GLP training.

3.4 Unit Production manager shall give technical training for the staff and the operators of Production department with the help of President- Technical.

3.5 Workmen training for both technical and basic rules of GMP shall be done in 'vernacular' language by respective supervisory staff on periodic basis.

3.6 Training should be conducted by a qualified trainer.

3.7 Corporate Managers will train the Unit departmental managers and subsequently will assess them through questionnaires and practical demonstrations.

3.8 The Corporate Managers will approve the departmental managers as “Qualified Trainer” based on the assessment.

3.9. Guidelines

3.9.1. NEW ENTRANTS : New entrants to the organisation shall be given induction training and a brief cGMP/GLP training by Manager QA within 10 days of joining. New entrants should be given technical training (need based) by the departmental manager depending upon the nature of job for one month. New entrant should be instructed to observe the activity in the recruited department for one month after the initial induction program. A written feedback is collected from new entrants after the training to ascertain his/her competence in both technical and cGMP skills. QA Manager shall prepare a regular annual schedule for training/retraining of technical staff. The Qualified trainer who has conducted the training should review and assess the feedback. Based on the assessment, trainer shall identify training retraining needs . Individual Training record should be maintained for each new entrant along with their feedback.

3.9.2. REGULAR TRAINING : Based on the need/requirement, a schedule along with a module should be prepared for the staff and accordingly training session should be conducted. A training session by the Unit departmental manager should be conducted for the following.
i. If any critical changes are made in the Standard Operating Procedure, training has to be conducted to the concerned departmental personnel
ii. If any new equipment is installed, the staff and the operator has to be trained on the operation, cleaning, Maintenance and trouble shooting for the equipment.
iii. If any new product is introduced, the nature of the product, manufacturing, handling and if any critical parameters to be maintained should be explained to production, Quality Assurance, Engineering and Quality Control personnel.
Analytical method will be explained to the Quality Control personnel by the manager For each of the above training session, the Quality Assurance personnel should issue a prior circular to the concerned department to intimate the details of topic, date, time and venue. of participants with their signatures should be documented during the training session by the Quality Assurance department. The trainer should prepare a questionnaire based on topics covered and issue it to the participants. The participants should write their answers and submit it to the trainer. The trainer should assess the participants based on their feedback. Based on the trainer’s assessment, retraining requirement should be identified by the trainer. The Quality Assurance personnel should file participants feed back in their respective training record. For any minor changes in SOP or process, the Qualified Trainer should give training at the work place and the same should be documented.

3.9.3. TRAINING SHCEDULE: New entrant
General factory rules and cGMP –10days
Technical training – one month Regular training for staff and operators
cGMP – Once in 6 months
GLP - Once in 6 months
Technical training – Once in 3 months A training session by an External Agency shall be conducted as and need/opportunity arises. Apart from the schedule, training/retraining sessions will be conducted as and when need arises.


This procedure gives guidelines of identification, collection, indexing, filing, access, storage, maintenance and disposition of Quality control records, including label controls of under test, approved, rejected labels and calculation sheets.

2.0. SCOPE:
Covers all the documents generated under quality system.

QC Chemists




6.1. The records created during the operation of the Quality system, identified, as Quality records shall be legible, securely identifiable and retrievable. They may be in the form of printed modes of magnetic media.

6.2. The releasing authority shall be responsible for maintenance, storage, retrievability and disposal of Quality records.

6.3. The Quality records shall be made available for evaluation to customer or his representation in case of contractual obligation.

6.4. List of Quality records stored with their location and retention period

6.5. Quality records maintained shall be indexed appropriately and such indexing shall be recorded in a register.

6.6. The Quality records shall be kept in a suitable environment to prevent damage or loss.

6.7. UNDER TEST, APPROVED, REJECTED labels and calculations sheets should be stored in a controlled area.

SOP No xxx

Note: Enclose a list of Quality Control Record and its Retention period as ANNEXURE


Sunday, September 21, 2008


1. Objective:
To lay down a standard procedure for Exit from Sterile Area.
2. Scope:
This procedure provides a standard guidelines to Exit from sterile Area.
3. Responsibility:
¯ Operator.
¯ Supervisor - Production.
¯ Senior Chemist.
¯ Head - Production.
4. Procedure:
4.1. In the third air lock remove the surgical gloves and keep it in the respective S.S Vessel containing disinfectant solution.
4.2. Enter into the second air lock; leave the slipper & sterile dress into a plastic dress bin for washing.
4.3. Enter into the first air lock wear the usual dress and exit.


1. Objective:
To lay down a standard procedure for destruction of the rejected ampoules / vials.
2. Scope:
Filled glass vials and ampoules which are rejected need to be periodically destroyed under proper supervision using the standard procedure.
3. Responsibility:
¯ Operator.
¯ Production supervisor.
¯ Head - Production.
4. Procedure:
4.1. Obtain the necessary authorization for destruction where ever applicable.
4.2. Check the labels on the bulk containers holding the vials / ampoules to be destroyed.
4.3. If the vials / ampoules to be destroyed are individually labeled and packed, then de-pack the vials / ampoules from the shippers and de-label these vials / ampoules by soaking them in a tub containing water and remove the labels.
4.4. De-seal each individual vial using a de-sealer and remove the stopper from each vial / ampoule.
4.5. Collect the contents of each vial / ampoule in a suitable container by emptying each vial.
4.6. Discard the collected contents into a drain after diluting the collected contents with water.
4.7. Consign the recovered stoppers and seals to scrap.
4.8. Crush the empty vials/ampoules.
4.9. Prepare the destruction certificate mentioning the product, batch number, quantity destroyed and reason for destroying.
Note: All the above process carried out in presence of a trained staff


1. Objective:
To lay down a standard procedure for Sterile Dress Washing and Sterilization.
2. Scope:
This procedure provides standard guidelines for Sterile Dress Washing and Sterilization.
3. Responsibility:
¯ Supervisor - House keeping.
¯ Chemist – Production.
¯ Head – Production.
4. Procedure:
4.1. Put the Sterile dress to be washed and sterilized, in plastic dress bin.
4.2. Washed with detergent powder followed by water. Finally washed with 0.1% Disinfectant.
4.3. Dry the washed dress in sun light and fold the dried dress.
4.4. Keep all the folded dress in SS Bins. Move the lid and keep open the holes.
4.5. Load the SS Bins into the Steam heat sterilizer and carry out the sterilization as per the standard procedure.
4.6. While unloading the box, keep close the holes by moving the lid. Then keep the dress bin in the second air lock which is ready for use.


1. Objective:
To lay down a Standard procedure for Sterile Area Entry.
2. Scope:
This procedure provides standard guidelines to enter into the sterile area.
3. Responsibility:
¯ Operator.
¯ Senior Chemist.
¯ Supervisor - Production.
¯ Head – Production.
4. Procedure:
4.1. In the first air lock remove the ordinary dress and slipper and keep neatly in the respective places, wash the hand and legs with soap solution followed by water.
4.2. Show the washed hands in front of Hand drier to dry.
4.3. Enter into the second air lock through cross over bench, wipe the hands with sterillium solution and wear the sterilized dress, sterile area slipper.
4.4. Enter into the third air lock, wear the sterilized gloves and walk on the germicidal mat containing disinfectant solution (dettol 5%).
Note: The person who is entering into the sterile area should not have any infection and wounds.


1. Objective:
To lay down a standard procedure for Sterile Area Disinfection
2. Scope:
This procedure provides a standard method for routine cleaning of sterile area using Disinfectants to ensure the area is completely free from micro organisms.
3. Responsibility:
· Senior Chemist - Production
· Supervisor - Production.
· House keeping
4. Procedure:
4.1. Remove all glass pieces if any, from sterile area after completion of the filling.
4.2. Clean the filling Machine, SS parts, filling table and floor with distilled water.
4.3. Use hot distilled water to remove the strain if present.Then use following disinfectants as per the schedule.

4.1. After cleaning, dry the sterile area for half an hour.
4.2. The Machine, table, laminar airflow should be wiped with decontaminating solution.
Decontaminating solution contains:
Liquid phenol 5% w/v
Formaldehyde 8% v/v
IPA 75% v/v
Distilled water QS
4.3. Spray the hydrogen peroxide solution 20% w/v (Virosil Pharma) after cleaning and wiping.
4.4. Finally, fumigate by using Formaldehyde and Potassium permanganate.

Saturday, September 20, 2008


To carry out the drying operation in an ordered sequence and to avoid untoward effects.
Operating Procedure
Check and certify that area and equipment are clean and suitable for starting the operation
Ensure that main switch is in “OFF” position before dismantling FBD for loading
Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley, take out the trolley along with the retarding chamber.
Check and certify the suitability of the clean finger bag
Fix the finger bag in a steel hanger, fix the loops of the finger to the hooks of the shaker
Place the bag in between the retarding chamber and fluidization chamber.
Clamp the retarding chamber on the body with fixing bolts
Load the bowl with material to be dried.
Place the product uniformity in the bowl to avoid lumps
Move the product bowl below the retarding chamber keeping the window in viewing position.
Position the bowl
Lift the bottom of the FBD by moving the jack handle to the opposite side and seal the trolley to the retarding chambers.
Check and ensure that there is no leakage
Set the timer and switch on heating and fluidization, maintaining the desired inlet air temperature.
Stop drying at intervals of specified in BMR and dedust the finger bag by shaking it.
Take out trolley and take the granules to avoid formation of lumps.
Watch the fluidization flow through the Perspex window
Continue heating till required outlet air temperature is achieved. Dry if mentioned in BMR
Put off the heater and bring the timer to zero.
Un loading
After drying is complete put off the main switch
Shake the finger load vigorously and de-dust retarding chamber.
Unlock and withdraw the board.
Status Label
Once the drying operation is over display the “To Be Cleaned” Status label


To carry out the drying operation in proper manner and to avoid the cross contamination of the granules.
Cleaning Materials
Cleaning Agent : Water
Cleaning equipment : lint free duster, nylon scrubber
Method of Cleaning
Procedure for Product to product change over
Clean the body of the drier and plenum with a dry clean duster. Then wipe it with a duster soaked in 0.1% teepol solution followed by a duster soaked in water.

Detach finger bag from hook by opening perplex windows in the retarding chamber

Unclamp the fixing bolts of retarding chamber & allow it to rest on the trolley. Take out trolley along with the finger bag and retarding chamber.

Remove the finger bag & bowel

Dedust the individual finger chamber of finger bag & keep it in a polythene bag. Send it for laundering
Take retarding chamber along with trolley and bowl with hot water scrubbing with clean nylon scrubber. Then wash them with 0.1% teepol solution, rinsing thoroughly with hot water followed by water. In case of sticky powder use steam

Wipe out the body of FBD retarding chamber, trolley & bowl by using a clean dry lint free duster. Further dry by running FBD at 70°C (without material) for 15 minutes.

Fix the laundered finger bag in a metallic hanger around the retarding chamber. Clamp the retarding chamber on the body with the fixing bolts. Lift the bottom of FBD and seal the trolley with bowl to the retarding chamber.
For Batch to Batch change over
Clean the body of the driers & plenum with dry duster
Clean the interior surface of the retarding chamber bowl with a clean dry duster
Clean the interior surface of the retarding chamber bowl, trolley.
De-dust the fingers of the finger bag.
If the cleaned FBD is not used with in 24 hours after cleaning or there are signs of dust or powder settled on FBD, then dedust the bowl retarding chamber & body by using a freshly laundered lint free duster.
Cleaning schedule
During every product & batch change over
Status label
Replace the “To be Cleaned” status label with “Cleaned and Ready for Use” label


To carry out the blending operation in a good condition, good operation procedure should be followed.
Ensure that the “Cleaned and Ready for Use” status label is present on the equipment.
During loading and unloading use gloves elbow size
Operating Procedure
Place the label containing the Name of the product, Batch No & Batch size over the equipment
Adjust the angle of the blender with the help of moving wheel to a required position for convenience in loading of materials.
Open the lid and load the materials from the container into the blender as per the sequence given in BMR, close the lid, put the safety pin on the lid by moving the wheel in clock wise direction.
Caution : Put the safety guard before commencementof the operation. Cover the area below the blender with polybags.
Switch ON the equipment & start the blending of material as per the time specified in the BMR
After the completion of blending switch OFF the instrument
Remove the poly bag and guard
Adjust the position of the blender at the said angle for convenience in unloading the materials.
Unlock the safety pin and remove the lid from the blender
Unload the blended materials
Status label
Place the “To be Cleaned” status label over the equipment


To carry out the mixing operation in a clean equipment according to the requirement of GMP.
Cleaning Materials
Cleaning agents : Tap water
Cleaning equipments : Dry duster, 0.1% Teepol
Disconnect the equipment from electrical main supply

Set the position of the blender vertical- butterfly value facing the floor.
Cleaning Procedure (For Product to Product Change Over)
Dismantle the safety guard of the blender, circular lid and gasket by unclamping the wing nuts
Clean the outside of the blender with dry duster followed by moist duster and then with dry duster.
Keep the butterly valve close and keep an SS container below it.
Wash inside the blender with tab under and drain it through butterfly value
Clean inside surface with warm water 40°C to 50°C followed by 0.1% teepol solution. Then wash with plenty of water to remove the teepol completely, then rinse with water.
Wipe the different parts of the blender with clean lint free duster.
Then assemble the dismantled parts.
For Batch to Batch Change Over
Dry clean the blender & lids with lint free duster and dedust the external surface with clean lint free duster.
If the cleaned blender is not used with in 24 hours after cleaning, outside of the blender and the lid should be wiped with wet duster followed by clean lint free duster
Cleaning Schedule
The equipment should be cleaned before and after every product to product and batch to batch change over. As per the above given method.
Status label
Display the “Cleaned and Ready for Use” status label after cleaning the machine.


Before starting the granulator check that all the parts comes in contact with the product are clean and also see that the machine is free from the previous batch particles.
Switch off the mains of the granulator and remove the old product labels.
Detach all the pars which have come in contact with the product and take them to the washing area.
Soak the mesh and other parts in water for about 15 minutes.
Use a nylon brush to remove the particles adhering to the mesh.
Clean the hopper, hopper lid, propeller and hopper ring with a plastic scrubber using 5 gms of Sodium Lauryl Sulphate solution in 1 litre of water as a cleaning agent.
Clean the above parts with a jet and rinse them with purified water, finally dry them by using air blower.
Clean the undetatchable parts with a nylon brush and wipe with wet cloth followed by dry cloth.
Assemble the parts on to the machine and affix a label stating that the machine is “CLEAN”
Check the oil in the gear box fortnightly and fill it with SAE – 40 oil if necessary.
Check the parts which come in contact with product for clean and clear the previous batch/product particles and dust from the room.
Fix the desired screen and tension it by tightening necessary knobs on to the hopper ring.
Fix hopper and stirrer in their position and fix the screen hopper ring by tightening the knobs.
Ensure that stirrer is not touching the screen under any circumstances. The clearance betwenn stirrer bottom surface to the screen must be about 1 mm for effective granulation.
Granulator is used for wet granulation, dry granulation and for tablet crushing.
For wet granulation 6# or 8# mesh are used, preferably with small size paddle type stirrer.
During wet granulation, there are chances of wet mass sticking to the stirrer joint, which Blocks the granulation. Under this circumstances remove the stirrer, clean it well and fix it in its position and continue the process.
Place clean and dry aluminium trays on the shelf rod to collect the wet granules for drying.
For dry granulation, and tablet crushing, use appropriate mesh (depending upon the size of the tablets) with big size paddle type stirrer.
In dry granulation process collect the granules into, clean labelled polylined drum for lubrication purpose.


It is essential to carry out the mixing operation in a clean equipment in order to avoid cross contamination.
Ensure that the equipment is possessing ‘ TO BE CLEANED ‘status label.
Make sure of that all the drums, drum cards, mixed and unmixed materials of the previous products are taken away from the section.
Keep the power switch for the machine in “OFF” position and disconnect the power cord.
Materials Required
Cleaning agents : Tap Water, 0.1% Teepol.
Cleaning Equipments : Lint free cloth, scrubber.
Cleaning Method
Dismantle the heart shaped beater from the central rod.
Remove the bowl from the cradle wash the beater and bowls with flowing water to remove the powders / granules adering to their surfaces.
Scrub the beater, the shaft holding the beater, the roof of the mixing chamber and the bowls with sponge using 0.1% Teepol. After scrubbing clean the scrubbed parts with pleanty of tap water. Visually inpsect the final rinse for absence of any solids.
Wipe the exterior parts – base and cover for motor, Reduction gear and trolley with clean lint free cloth.
The above cleaned parts are dried with wiping with lint free cloth and ressembled in the reverse order.
Cover the machine with a fresh clean cloth cover if it is not used immediately.
Inform the supervisor to check the cleanliness of the equipment.
Cleaning Shedule
Sign in the log book and maintain the log book properly.
Before starting and after finishing the work and Batch to batch change over.
Status Label
Affix the ‘CLEANED AND READY FOR USE’ status label after the completion of cleaning.


To remove any left over adhering powder thereby to avoid cross contamination.
Materials required for cleaning
Cleaning agent : DM water, tap water
Cleaning of equipment : Muslin cloth, nylon brush
Cleaning Procedure
Switch OFF the power supply.
Clean the lid with vessel of the mixer with the jet of tap water.
Thoroughly wipe the outer portion of the machine with clean and dry cloth.
The mixer is rinsed with hot tap water to remove adhered lumps of powder.
Clean inside of the mass mixer with a jet of tap water till all the powder sticking is completely removed. Then use nylon brush for cleaning.
Care should be taken that all the corners of the mixer and loaffles are thoroughly brushed & cleaned.
Remove the water and rinse with fresh hot DM water and dry it by using clean muslin cloth.
After getting approval from QC display “CLEANED” status label.
If the mass mixer is not in use, protect the mixer by covering with polythene bag.
Cleaning Schedule
Before starting manufacturing operation and after completion of the manufacturing operation
Status label
Display “Cleaned and Ready for Use” status label after the completion of cleaning.


To carry out the mixing operation in an orderly sequence and to eliminate any untoward effects.
Operation Procedure
Loading of Materials
Load the materials from the containers / drums into the bowl as per the sequence specified in the Individual product BMR.
Close the lid and lock the 3 locking clamps
Stick a card possessing the batch no, product name, batch size of the product to be mixed.
Put the main switch ON
The operator and other person involved in the manufacturing should wear clean hand gloves, head cap and nose mask.
After all the required materials are loaded into the mass mixer, it is allowed to run for the required time as per the Individual product BMR
Add the binder / paste – binder solution by opening the lid, then run the mixer to the required time as per the Individual product BMR
Packing is done if required and mainly in the center of the bowl
After the wet mixing, discharge the wet mass into the bowl by opening the discharge lid at the bottom
Stop the mixer and open the lid and remove the remaining mass by scrapping it with Teflon scrapper. Ensure that all materials has been unloaded.
Status Label
Display the status label to “TO BE CLEANED” once the mixing operation is over.


1. Open ‘B’ and ‘D’ and allow the raw water to pass through bed for 10 minutes.
2. Close ‘B’ and ‘D’. Allow the bed to settle for 10 minutes.
3. Preparation of Soda Solution
Take 12 litres of D.M. water into the caustic tank, weigh and add 0.75 kgs of caustic soda into the tank under stirring. Ensure completely dissolved.
4. Soda Injection
Fill regeneration tank used for regenerating purpose with 5 litres of soda solution. Connect the regenerant inlet and compressed air pipeline to the regenerant tank. Open E and G to allow the soda injection to take for 10 minutes by adjusting the air pressure. Close E and G. After soda injection close E and G and stop compressed air supply.
5. Soda Rinse
Open E and G. Connnect regenerant inlet to raw water. Rinse for 20 minutes. Close E and G.
6. Preparation of Acid Solution
Take 5.5 litres of D.M. water into the acid measuring tank, pour 1.8 litres of acid and stir to get uniformity.
7. Acid Injection
Fill the regenerant tank with 3.5 litres of acid solution. Connect the regenerant inlet and compressed air pipeline to the regenerant tank. Open F and H to allow acid injection to takes place for a period 10 minutes by adjusting the air pressure. Close F and H. Repeat the process by filling the regenerant tank with remaining 3.0 litres of acid solutioon and repeat the process by opening F and H.
After acid injection close F and H and stop compressed air supply.
8. Acid Rinse
Connect the regenerant inlet to raw water supply. Open F and H and rinse for 20 minutes. Close F and H.
9. Air Mixing
Connect air inlet to air blower, open D and air inlet valves. Give air mixing for 20 minutes. Close D and air inlet.
10. Final Washing
Open A and C and wash the resins with water through raw water inlet until the conductivity reads 1 micro seimen/cm.
11. If the right conductivity reading is not obtained, perform air mixing and final washing process once again to get the conductivity.


1. Preparation of Acid Solution
Take 22 litres of D.M. Water into the acid measuring tank, pour 10 litres of acid and stir to get uniformity.
2. Preparation of Soda Solution
Take 32 litres of D.M. Water into the caustic tank. Weigh and add 2.4 kg of caustic soda into the tank under stirring. Ensure completely dissolved. Allow the solution to get cooled before regeneration.
3. Acid Injection
Fill the regenerant tank with 16 litres of Acid Solution. Connect the regenerant inlet and the compressed air pipeline to the regenerant tank. Open “B” to allow acid injection to take place for period of 15 minutes by adjusting the air pressure. Close ‘B’. Repeat the process by filling the regenerant tank with remaining 16 litres of acid solution and by opening ‘B’. After acid injection close ‘B’ and stop compressed air supply.
4. Acid Rinsing
Connect the regenerant inlet to raw water supply. Open ‘B’ and rinse the resins for 20 minutes. Close ‘B’
5. Before starting Soda Injection, close the pipeline which leads from the junction to “Conductivity Cell” by using a plug, (As soda solution is not allowed to enter the conductivity cell).
6. Connect the raw water inlet to raw water supply. Open ‘C’ and ‘D’ and allow the water to go through for 5 minutes. Close ‘C’ and ‘ D’ wait for 5 minutes.
7. Soda Injection
All the regenerant tank, with 16 litres of soda solution, connect regenerant inlet and compressed air pipe to the regenerant tanlk. Open A and D to allow the soda injection to take place for 15 minutes by adjusting the air pressure. Close A and D and fill the regenerant tank with remaining 16 litres of soda solution. Repeat the injection process by opening A and D. After soda injection close A and D and stop compressed air supply.
8. Soda Rinsing
Open A and D, connect regenerant inlet to raw water. Rinse for 20 minutes close A and D.
9. Final Washing
Open raw water supply, and open C until conductivity is attained.
10. Collect the water only after getting the conductivity less than 30 microsiemens/cm.


1. Switch off conductivity indicator
2. Close all valves and pinchcocks including raw water supply.
3. Raise regenerant bag, lock in position and the open the lid.
4. Preparation of Acid solution
Pour 6 litres of commercial grade Hydrochloric acid in anticorrosive container and 15 litres of D.M. water to dilute.
5. Acid Injection
a. With all valves closed, disconnect raw water inlet tube and lead it to a drain. Pour 7 litres of the prepared acid solution into regenrant bag. Open valve B and pinchcock P2.
b. Adjust flow of acid to drain by means of pinchcock P2 such that the flow is approximately 1 litre per minute. Repeat a) and b) till all the prepared solution is used.
6. Acid Downflow Rinse
Pour 20 litres of D.M. Water in the regenerant bag in three lots.
7. Preparation of Soda Solution
Dissolve 1.2 Kgs of caustic soda in 21 litres of D.M. water. After caustic soda is completely dissolved pour in the regenerant bag in three lots.
8. Soda Injection
a. Open pinchcock P3 and valve “A” fully. Open and adjust valve D such that regenerant bag emloties in 10 minutes, then close valve A and D.
b. Repeat the above operation till all the prepared solution of soda has been used up in lots taking precautions against air locks.
9. Soda Rinse
a. Take 15 litres of D.M. Water to be poured into the regenerant bag in two lots.
b. Open valve A and D to get flow one litre per minute, close valve when regenerant bag is almost empty.
c. Repeat the above operation till all the D.M. Water is used up.
10. Final Rinse
Open pinch cocks P1, P2 and P3, open valve C and raw water supply valve, regenerate these two valves to give flow of 3.5 litres per minute. Switch on the conductivity meter after some time and when conductivity reaches an acceptable level collect the water for Service.


1. Ensure water fed to the softening plant is free from suspended particles, Iron, organics, oil, slime, heavy metals.
2 Regeneration of the softner plant is being done whenever the water quality detoriates, (confirm by test given below).
3 Regeneration:
3.1. Dissolve 10 kgs of commercial grade Sodium Chloride in about 60 Liters of raw water in water softner injection tank.
3.2. Back wash for 10 minutes with Raw Water
3.3 Inject the brine solution (Down flow) with the help of the Ejector.
3.4. Remove Calcium and magnesium salts formed during regeneration and excess brine by down ward flow of raw water. (Approximately 15 to 20 minutes)
3.5. Up-Rinse the softner for 15 to 20 minutes with raw water.
4. check the Quality of water by the following method.(Hardness less than 1mg/lit) following method.
Take about 100 ml of soft water and pour it into a round bottom flask. Add 1 tablet of total Hardness indicator tablets. Shake well till the tablet completely dissolves. Add 2-3drops of Ammonia Buffer solution.
If a steel blue colour without pink tinge is obtained the hardness will be less than 1mg.
If a pink colour is observed, add N/50 EDTA solution drop by drop until getting a steel blue without pink tinge.
Each drops of EDTA solution added is equivalent to 1 mg/Lit of total hardness in water.
5. Send sample to Quality Control for analysis.


1. Open the drain valve of the receiver tank, drain the water and close
2. Check oil level in the viewer. Ensure that the oil occupies not less then 50% in the viewer
3. Switch on the cool water pump. Ensure that the water pressure is between 2-3kgs/cm2
4. Put the main Switch ON. The light under “SEE POWER ON” will glow
5. Put the start button ON. The light Under “Running ON” will Glow
6. Put the remote in Automode
7. Press the “LAMP TEST” and confirm that light glows under the following headings.
a. separator
b. oil filter
c. reverse rotation
d. high sump pressure
e. high discharging pressure
f. motor over load
g. low water pressure
8. During normal service if any of the indicator
9. During normal service sump pressure will be at 8Kgs/cm2 and on line pressure will be around 6.0Kgs
10. Unloading of the compressor will takes place at a pressure of 8Kgs/cm2 and loading will takes place when the pressure comes down to 6Kgs/cm2.
11. The air will be started collecting in the receiver.
12. Change oil filter every 250 Hrs. of running.
13. Change Elgi Airlube screw compressor oil for every 500Hrs. of running.
14. Record dates timing of all the operations.

Reciprocating Compressor
1. Open the drain valve of receiver tank. Drain the condensed water and close.
2. Ensure oil level, it should be up to the mark as indicated in the viewer.
3. Ensure that the delivery valve is in closed condition.
4. Shut the main switch and compressor is SWITCH ON the Air pressure will develop gradually.
5. When the Air pressure reaches 5Kgs/cm2, open the delivery valve and maintain the pressure at 8Kgs/cm2.
6. The operating pressure is between 9-12Kgs/cm2 Unloading the pressure takes place, and when the pressure comes down to 9.0Kgs/cm2. loading takes place automatically.
7. Change castrol CRD30 (MIL-C-SAE 30) oil every month.
8. Record date and timing of all the operations.


1. Ensure: Quality of water. The hardness of water should not exceed the limit of 2PPM.
2. Ensure levels of LDO/Diesel & soft water in tanks.
3. Ensure steam temperature is set at –195°C.
4. Ensure drain valve of economizer, fuel strainer drain valve and coil blow down valve are closed.
5. Open control valves of water, LDO/diesel.
6. Put the electronic main switch ON. Observe the white control lamp comes ON.
7. Close main steam valve and open the auxiliary steam valve.
8. Put the Fill switch on to fill up the coil.
9. When the water starts coming out of the auxiliary steam valve, the unit is ready for firing. Ensure at this line that all the red lamps are off and only the white control lamp is on at this stage.
10. Press Fuel circulation switch for about half a minute so that Fuel pressure builds up to about 2kgs/SQ cm.
11. Put the fire switch on. Blower, Fuel Pump and water pump will start.
12. Ensure that the green “burner on” lamp comes ON.
13. When the steam pressure gradually builds up to 5kgs/cm2, open the main steam stop value gradually and close the auxiliary steam value simultaneously.
14. Ensure while running the boiler the following are maintained
a. Steam pressure between 9kgs-6kgs/cm2 .
b. Water pressure at 50 bar.
c. Feed water temperature at 80°C.
d. Steam temperature between 170°C-190°C.
e. Fuel pressure at 12kgs/cm2
1. Close the steam stop valve fully. The pressure switch will cut off the boiler automatically.
2. Put the fire switch off.
3. Open the coil blow down valve fully. Once blow down is over close the blow down valve and open the auxiliary steam valve fully.
4. Drain the economiser by keeping its drain valve open till clear water starts coming out.
5. Put the Fill switch ON and Fill up the coil with water. When the steam temperature indication falls below 90°C, put the fill switch off. Close the auxiliary steam valve.
6. Put off the heater switch.
7. Put off the electric main switch.
8. Clean any dripped oil, water…etc.
9. Close the outlet values of water service tank and LDO/Diesel service tank.
10. Record timings of operation & fuel consumption.


Object & Scope
Identifying the basic characters of machine like capacity, power requirment,(voltage, / current) name of the make etc Problems Observed & Rectification Details
History cards are maintained for each and every machines and equipments as per the enclosed format
History card gives the performance of the machine (ie) types of problems observed, frequency, how it is rectified, the preventive maintenance to be taken to avoid the regular repeated problems.
It also gives the idea about the reputability of the machines and equipments manufacturer (vendor Validation)
Name of the Equipment:
Capacity :
Make :
Voltage :
Frame :
Current :
Speed :
Date of Installation :
Conn. :
and Coloumns for the following for entering day to day date

Problem Observed
Remedy Taken


Objective & Scope
In order to maintain the machines and eqipments properly a team is formed with an engineer as a head with 3 technical persons as assistants
01. He will be reporting to works manager.
02. He is responsible for achieving total production target and reducing rejections within the norms
03. He should plan for a total preventive maintenance schedule for all the machineries and should see that it is implemented and followed up regularly at the required intervals and also proper records should be maintained.
04. He is also responsible for immediate rectification of all breakdowns, reducing down time of the machines to the barest minimum.
05. He is responsible for total inception, planning, procurement, erection and commissioning of new projects, which are being handed over to him from time to time.
06. He should try to develop spare parts indigenously or locally, thus reducing the high cost involved in the procurement and storage of expensive spares.
07. He is totally responsible for work allotment for whole of his engineering team and also plan continuously to build a highly dedicated and motivated team.
08. He is also responsible for sending the daily reports, monthly reports and all other MIS activities for the top management.
09. He should put his maximum efforts in improving
a. Safety standards
b. Environmental cleanliness
c. Quality
d. Profitability
He is also responsible for the following things in liaison with Engineering Supervisor.
a Inventory control of spares.
b Keeping stock of oils and lubricants.
c Annual maintenance contract
d Maintenance of all engineering records
e Control of personnel in Engineering Department.
f Statutory clearances like ceig approvals, Explosive clearance etc.
g Payment of Electricity Bills & Fuel Bills etc.,


Object & Scope
Maintenance of various essential utility equipments in good condition. Achieve good output and less maintenance expenses, by adopting the following procedures.

The major equipments covered by the utility department are:

In order to maintain the machines and equipments in good condition the following SOP’s are adopted

1. Fixing Duties & Responsibilities Of Maintenance Engineer

2. Maintenance Of History Card For Machines And Equipments

3. Standard Operating Procedures For Machines

4. Preventive Maintenance Schedule Procedures For Machines And Equipments

5. Check List For Preventive Maintenance For Various Machines And Equipments

6. Log Sheets For Machines And Equipments


1. The Standard Operating Procedures should be numbered and dated. Suitable alphabetical prefix should be given in the numbering in order to indicate the department in which the document has been created.
Following alphabetical prefixes are assigned to various departments
The first LETTER shows
G – General
U – Utilities
W – Water System
MF – manufacturing
Q - Quality Control / Quality Assurance

The Next LETTER Shows subdivision of the main area
BS - Building & surrounding
H – Hygiene
S – Sanitation
SF – Safety Manual
B - Boiler
G - Generator
A - AHU (Air handling unit)
D - Dust Extraction System
CL - Cleaning
PM - preventive maintenance
OP - Operating Procedure
CAL - Calibration procedure
GP - General Procedrure
MB - Microbiology procedure

2. SOPs should be numbered in Serial, like 001,002,003.
3. Any revision in the existing SOP will bear the same serial No. followed by Stroke `/’ and revision number in serial.

For example : GH 001 denotes g for general category
h for hygieneic operation belongs to general category
001 denotes the first SOP.


To describe the procedure for the preparation, implementation and control of Standard Operating Procedures
Responsibility : Manager - QA, All Head of the Departments.
A. General
A Standard Operating Procedure (SOP) is a written approved procedure which describes how to perform a operation in a plant. It is not necessarily specific to a given material or product but is of a general nature.
Standard Operating Procedure (SOPs) should be created in every department of the factory and should cover the various phases of a manufacturing operation and its control. They must list by steps what must be done and how it is to be done.

B. Writing of SOP
1. Department Head will write the SOP and will submit to Manager - QA for approval.
2. The title should be clear and should indicate the nature and purpose of the document.
3. Where the procedure bears instructions it should be in the imperative and in the form of the steps.
4. The contents should be clear, precise and unambiguous, the language should be such that the user can easily understand them.
5. The size and shape of the document and the quality and colour of the paper used should be such that typing or printing, reproduction and filing become easy and simple.
C. Approval of SOP
1. SOP becomes operational only if it is signed and approved.
2. The signatories should include the person who writes the document, i.e. the representatives of Engineering, Production, Quality Control, Quality Assurance, Management review department and the person who approve the use of the procedure. All SOPs will have signature in black ink.
3. Manager - Quality Assurance will approve all the procedures which will have impact on the quality of the Company’s products.
4. In case of non-availability of Manager - Q.A., works manager can sign.
5. Master copy of SOPs of all departments will be kept with Q.A. Department. These copies will be stamped “MASTER COPY” in blue ink on top right corner.
6. All department copies of SOPs will have a stamp “DISTRIBUTION COPY” in blue ink on top right corner.
D. Implementation of SOP
1. Once SOP is approved, which needs to be circulated to any Department. Records of the circulation will be maintained by QA Department
2. An approved SOP should not be altered until any required or desired change is accepted by the individual concerned for the implementation of the SOP.
3. If a procedure is to be changed it must be re-written and again approved before the change is implemented.
1. The revised SOP should be given a new number and it should indicate which number SOP it supersedes, date effective, next revision date and page numbers.
2. An outdated or superseded SOP should be removed from active use. Master copy of superseded SOP should be kept in a archive file with “OBSOLETE” stamp in red ink across the page for reference at any time and all controlled copies will be destroyed.
E. Distribution of SOP
Master copy of Approved SOPs will be kept with QA Department. The list of SOPs distributed to various departments and number of copies distributed will be prepared and kept with QA Manager. If any additional copies are required in the later date a copy of master copy will be issued by QA Manager / Manager - QA with a signature on each page at the bottom after stamping “ISSUED BY” in blue ink.

F. Review of SOP
All SOPs will be reviewed and if required, they will be revised by the respective Department Heads as and when it is necessary and all SOPs must be reviewed after two years within the 2 months period. The revised SOPs will be approved by the Manager - Quality Assurance
Any SOP when reviewed after the due date which does not require any change or revision, will be kept as it is but will have following stamping at bottom on all pages :
Reviewed on : Reviewed by :
Valid upto : Approved by :

The above stamping will be in blue ink and signed and dated by authorised persons.
Each sheet of the SOP shall show in the header as under:
1. Name of Department
2. SOP No
3. Next review date
4. Title
5. Effective Date
6. Prepared by
7. No of pages
8. Superseds SOP No
9. Approved by
10. Authorised by
Between two horizontal lines, the applicable title of SOP shall be described.

Wednesday, September 17, 2008

Cleaning & Assembling Procedure for Punching Machine (Cad Press)

As soon as the compression of a particular batch is used, transfer the punched goods to packing and disconnect the electrical supply to the machine and carefully dismantle the following parts.
Feed hopper, Acrylic guards, feed frames, turret guards, corer plate of the worn shaft nylon break plugs along with the spray steel strips, die screws tablet collecting chutes dust collecting wood assemblies.
Clean all the above mentioned parts along with relevant bolts thoroughly with hot tap water and keep them aside.
Cleaning procedure for Punches, dies and machine :
Remove carefully all the lower punches by removing the plug and keep these punches in a specially designed wooden tray, serially arranged, similarly remove all the upper punches and keep them in a separate wooden tray serially arranged, remove all the dies with the help of a SS rod and keep them serially arranged in one of the above trays.
Clean the exterior portion of the machine by wiping it with a lint free duster soaked in special denatured spirit.
Clean all the interior areas of the machine like base plate on which the turret is fitted, camtracks, die seats, upper and lower punch holes, turret surface, first with a dry nylon brush and then with special denatured spirit.
Precaution: While cleaning punch holes turret surface and die seats ensure that they are free from any particulate matter.
Clean the entire area by vacuum cleaner.
Take about 2 liters of hot tap water, 10% teepol mixture and clean all the punches by dipping each in hot water teepol mixture and then clean thoroughly with hot tap water and after cleaning all the punches and dies should be put serially in the clean wooden trays meant for storing them.
Use 15 liters of distilled water and give couple of washes to the cleaned parts and the dismantled punches and dies. Inspect the final rinse water for presence of any suspended matter. If it contains any suspended matter repeat the washing until rinse water is free from suspended matter.
Wipe all the cleaned parts with clean dry lint free clothe.
Precaution : Before filling all the dies ensure that they are free from any foreign matter.
Plug the required product die face downwards on the die hole, apply light pressure with fingers on the top phase of the die and place it centrally over the die hole. After setting the die correctly, drive the die into its position with the help of SS rod introduced through the upper punch guide holes. Once the die is fitted, the top position of the die should flush with the turret surface. Now introduce all the screw and tighten again check whether the die surface flush with the turret surface.
Take a lower punch, wipe it dry, smear with liquid paraffin and introduce it through the lower punch die hole, while doing it so ensure that each numbered punches goes into its corresponding compression station. All the lower punches thus introduced should move freely up and down place the plug back into its position. Fix all the cleaned and dried nylon plugs with spring steel strips.
The cleaned and dried upper punches should be smeared with liquid paraffin and introduce into their corresponding holes
Assemble the cleaned dust collecting hood assemblies
Cover the cleaned machine with a clean cloth cover and affix “CLEAN & READY FOR USE” label on the machine.

Cleaning and Operating Procedure for Sifter

The sifter is used to sift the various excepients such as Starch, Talcum, Magnesium Stearate, Stearic Acid etc. It is also used to sift active materials also. Proper cleaning of the sifter at the end of sifting process ensures prevents of cross contamination.
As soon as the sifting process is over, dismantle the following parts:
a. SS feed hopper
b. SS frame, holding the sieve in place
c. SS wire mesh sieve.
1. Remove all the residual powder adhering to the above mentioned articles with the help of a nylon brush.
2. Wash these articles with the help of running hot water.
3. Wash these articles with sponge using 0.1% TEEPOL.
4. Clean these articles with running hot water for at least 10 minutes to remove all traces of detergent.
5. Drain off all the water and dry all the articles with the help of a hot air blower.
6. Clean the exterior of the sifter stand and motor assembly with the help of a lint free wet cloth.
7. Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter stand.
8. Assemble all the cleaned / drier articles from step 5 on the sifter stand frame.
9. Affix a cleaning label incorporating the following information :
a. Name of the Equipment
b. Name of the last product sifted
c. Name of the operator who cleaned the equipment
d. Date of cleaning
e. Supervised by
f. Caution : Please clean before use.
It is essential to use the powdered excepients and the active materials for the manufacturing of tablets which are free from any extraneous materials like black particles, wooden or metallic particles or any pieces of the packaging material. This is necessary to prevent entry of these extraneous materials to the finally compressed tablets. Presence of such extraneous materials is also not advisable from the aesthetic point of view since the description of any colored or white tablet defines absence of any extraneous material. Due attention should be given to the sifting activity.
To impart horizontal rotary motion to the particle by gyrator vibration generated out of balance flywheel. Due to absence of vertical movement, bouncing of the particles does not take place and thus presenting permanent clear screen apertures. The above machine is used to sift cornstarch, magnesium stearate and talcum (through 100 # SS screen) in order to obtain a material of uniform particle size and free from foreign particles.
1. The portable sifter, fitted with sturdy castor wheels is placed near the air exhausting system.
2. Suitable size SS screen mesh is fitted on the machine and then locked with the charging port.
3. The operators should wear nose mask, goggles and hand gloves while handling the material.
4. The amplitude of vibration is adjusted by movable weight on the flywheel.
5. The amount of material on the screen should be small so that passage of small particles is not obstructed by larger particles.
6. The motion should not be too vigorous so as to cause size reduction of the particles or damage to the screen.
7. The sifted material is collected in a clean polyethylene bag fitted in a clean container / bucket. The dust and other particles remaining over the screen are thrown away. Poly ethylene bag is tied with a thread++ tightly and the container / bucket closed with a lid. The container is to be properly labelled.
8. After completion of sifting of the material the changing port, the wire mesh screen and the other SS parts coming directly into with the product are cleaned with hot water and drier. The other parts of the machine are cleaned by using vacuum cleaner.