Tuesday, October 13, 2009



To specify norms for clothing to be used at workplace.

Explanation : Appropiate clothing at workplace, footwear and headgear are extremely important from safety point of view.


2.1 Get dressed for work wearing clothing, headwear and shoes prescribed for the type of your work.

2.2 Wearing of neckties, scarves, ornaments like bangles or loose necklaces, earring etc. may prove hazardous while working on or near moving or unguarded parts of machines and hence should not be worn while at work.

2.3 Never wear loose fitting sleeves when working on moving machinery.

2.4 Laboratory overalls should be worn while working in laboratory to avoid chemical contamination and for the purpose of personal safety.

2.5 Work clothing should be regularly laundered and kept in good repair.

2.6 Appropriate sterile uniforms should be worn while working in sterile area. A suitable laundering and sterilization schedule should be followed.

2.7 Protective wear such as caps, helmets, safety footwear, gloves, masks and goggles must be used as per job requirement. Other appropriate personal safety equipment should be used while carrying out hazardous jobs.

Friday, October 9, 2009



Purpose of this SOP to establish and provide procedure for carrying out Pest and Rodent Control Operations.


This procedure is to be followed at Vital Healthcare. This procedure is very essential to maintain the clean and hygienic condition in the factory premises and process areas. This is also to avoid damage to the material in the factory premises.


Concerned Operator who has given the work should follow the procedure and concerned supervisor should ensure that procedure is followed correctly.


Pest and Rodent Control Plan, Rodent Trap, Approved Pesticide and Rodenticide, Spray pump, Safety Goggle, Nose mask etc.


5.1 Rodent Control

a) Use only in house approved rodenticide for rodenticide treatment. At present rodenticide containing 0.005 % W/W Bromodiolene and Zinc Phosphide are approved

b) Rodent control should be accomplished with the use of mechanical traps with anticoagulant bait placed inside the trap in small trays / dishes, if required Glue pots are used

c) No open baiting is permitted.

d) The mechanical traps should be numbered serially and their latest location should be indicated on plant map (Fig. I).

e) The mechanical traps should be inspected and a record should be maintained about the observation by the supervisor. Observations should be recorded in “Rodent Control Record”.

f) If a rodent is caught in a trap, it should be disposed off suitably and the trap should be cleaned with water thoroughly.

g) The baits should be changed after fifteen days.

5.2 Insect Control

6.1.1. The area inside the plant should be sprayed with insecticide.

6.1.2. Malathion type insecticides should not be used.

6.1.3. Pyrethrum / Lindane / Cypermethirn type insecticides should be used.

6.1.4. While spraying extreme precaution should be taken and only the area shown in plan should be sprayed.

6.1.5. The spraying should be record in fly control record.

6.1.6. The spraying of insecticides should be done once in a week.

All rodent & pest control activities are to supervised by authorised supervisor and record should be maintained.

6.3. Insectocutors :-

6.3.1. The insectocutors should be placed as shown in figure I.

6.3.2. The insectocutors should be kept on as per Appendix I and record should be maintained.

6.3.3. The insectocutors should be cleaned weekly and a record should be maintained. Cleaning should be done by maintenance department.


After two years or when procedure is changed.

Thursday, October 8, 2009


1.0 Company Information

1.1 Human and Financial resources.

1.2 Knowledge of GMP requirements

1.3 Organization

a) Structure

b) Responsibilities.

1.4 Customer Support

a) Installation and service.

b) Technical support

c) User training.

2.0 Quality System –General.

2.1 Management’s stated policy and commitments.

2.2 Quality group’s responsibility and authority.

2.3 Written Company quality plan.

2.4 Management Review of quality system.

3.0 Quality System –Software Development.

3.1 Development Plan

a) Functional Requirements.

b) Software design specifications.

c) Programming standards and procedures.

d) Programming tools.

e) Review procedures.

3.2 Test Plan

a) Types of Tests.

b) Test tools and methods.

c) Error correction and re-test.

d) Test review.

e) Acceptance criteria.

f) Test reports.

3.3 Configuration Management.

a) Organization and responsibilities.

b) Identification and traceability.

c) Configuration tools.

d) Change control procedures.

e) Version identification control policy.

f) Release approval procedures.

g) Configuration history and status report.

3.4 Program Documentation

a) Source code.

b) Logic diagrams.

c) List of all inputs and outputs.

d) List of all modifiable parameters.

e) List of all operator inputs.

f) Description of interfaces to other systems.

g) Description of alarms and interlocks.

h) Description of error detection and recovery.

i) Description of all data displays.

j) Description of all reports.

3.5 Document Control

a) Documents to be controlled.

b) Approval of issue procedures.

c) Change control procedures.

d) Retention and security procedures.

3.6 Personnel Qualification

a) Formal education.

b) Internal training.

c) Experience in software development.

d) Experience with specific programs used.

e) Experience with application.

4.0 Product Information

4.1 Validation Features.

a) Security.

b) Self documentation.

c) Automatic program change audit trail.

d) Simulation capability.

e) Program compare.

f) Revision documentation detail.

4.2 History of Use

a) Customers of all version.

b) Customers of present version.

c) Configuration history and status report.

4.3 Expected File

a) Present version

b) Revised products.

4.4 Revision Policy

a) Notification of problems.

b) Change required to fix problems.

c) Change to add or modify features.

d) Notification of revisions.

e) Support old versions.


1.0 Formaldehyde Solution 37% (Formalin) sufficient to vapourise about 35 ml of Formalin for each cubic metre of enclosed space.

a) Large stainless steel evaporating pans.

b) Thermostatically controlled hot plates.

c) Small stainless steel canisters with perforated stainless steel lids. Polyurethane pieces.

d) Adhesive tapes

e) Goggles

f) Aseptic area garments, duly sterilized

g) Thermometers

h) Petri dishes with nutrient agar media.


2.1 Formalin is a strong irritant and is toxic. Inhalation of formaldehyde gas should be avoided since it cause irritation of the respiratory tract. Contact with the skin should also be avoided.

2.2 When Formalin is being handled, protective clothing inclusive of rubber gloves and goggles must be worn.

Personnel must leave the area being fumigated as soon as possible after placing the pans of Fornalin on the hot plates.

2.1 The area being fumigated must be sealed off and all entrances to the area must be locked. The area should not be re-entered until the fumigation is completed.

2.2 When fumigation is over, personnel should enter in teams of two or more and only after ensuring that all gas has been removed from the area by estimation of the concentration of formaldehyde by means of a Draeger gas detection tube.

2.3 All the stages of fumigation should be supervised by responsible personnel who should be inconstant visual contact with the operator to assist them in the event of any accident.

2.4 All persons coming in contact with for formaldehyde solution must wash their hands and faces thoroughly with soap and water before eating and/or drinking.


3.1 Effective fumigation requires a minimum temperature of 25"C and relative humidity of at least 50% for the duration of fumigation.

3.2 The areas being fumigated must be completely shut off from other areas of the plant during fumigation.

3.3 At the end of the fumigation period, the area must be ventilated aseptically in such a way that vapours of formaldehyde are completely exhausted to the atmosphere and are not carried into other , areas of the plant.

3.4 Operators should not re-enter fumigated areas until the level of formaldehyde vapours is reduced to less than the threshold limit valve ( T. L. V. of 2 parts per million.

3.5 Fumigation is best carried out immediately prior to the weekend. The area can then be ventilated over the weekend and so may be safely entered on the next working day.


1. All materials, products and equipment that might be damaged or contaminated by formaldehyde should be removed.

2. The room and remaining equipment should be cleaned ,and disinfected using a suitable disinfectant solution such as a 3% solution of Dettol followed by a 0.5% solution of Savlon.

3. With the help of adhesive tapes, all cracks, crevices and openings from the outside should be sealed off leaving only one door open for personnel to leave the area after placement of the evaporating pans. This door should also be sealed off later, after al] the persons have left the room.

4. All exhaust fans and booster fans, should be shut off and the air in-take port ,and outlet to the atmosphere made up suitably.

5. All ultr,l-violet lights should be shut off.

6. Depending on the size of the room one or more stainless .steel evaporating pans should be placed in the room to be t-umigated.

7. Thermometers should be placed strategically throughout the area in such a way that they can be viewed from outside the area.

8. Inside the filling cabinets, sterile polyurethane pieces impregnated with 6 to 8 drops of formaldehyde and enclosed in the stainless steel canisters should be placed.

9. Taking adequate precautions, the operator should pour sufficient formaldehyde solution into the evaporating pans kept on hot plates. The heating should be switched on.

7. The air-handling system supplying the aseptic area .should be switched off.

The area to be fumigated should be evacuated and the exit door sealed.

12. All the doors should carry the signs "Danger – keep out fumigation in progress.

13. If the temperature of the areas is below 25 C, steam coil heaters or electric coils may be used for preheating the areas to 25"C.

14. The temperature setting of the hot plate should be suitably adjusted and the vapours of formaldehyde should be allowed to slowly diffuse in the areas after ensuring that the main door is sealed. The fumigation should be done for at least 25 hours and the temperature of the area should be recorded at frequent intervals.

15. At the end of 36 hours, the air handling system should be switched on the it should be ensured that fresh air replenishment occurs to the fullest extent.

16. Entry by at least two operators at a time .should be made into the fumigated area and the evaporating pans and hot plates should be removed.

17. The aiir handling system controls should be readjusted to the normal operating cycle.

18. Two or three hours after the removal of the formaldehyde pans the sterile area surfaces should be wiped with a solution of Savlon or any other disinfectant, using sterile sponges.

19. With the ultra – violet lamp circuits switched off, the lamps should be wiped with a 70% solution of isopropyl alcohol. The alcohol should be allowed to evaporate completely and then the lamps should be turned on.

20. Petri dishes containing nutrient agar media should be exposed at various places in the area to monitor the microbial load.

Wednesday, October 7, 2009



To provide format and guidelines to participate in the implementation for infestation prevention and treatment of pesticides from areas in which manufacturing and packing are carried out or raw materials, Finished products or Packing components are stored. (Rodents, Insects, Cockroaches, Bed Bugs, Ants, House flies, Bandicoots, Mosquitoes, Flies, Lies, Mites, Picks)


This procedure is design to ensure the exclusion of Rodents and insects from all areas of the plant.


Pest control ( India Ltd. ) Jalgaon on yearly basis.



This treatment aims at controlling all crowling Insects, pests mainly Cockroaches, Bed bugs, Silver fish, Ants, Red & Black ants & Similar other crowling insects in the plant are carriers of pathogens of causing diseases like Gastric Enteritis, Cholera vibris etc.

Mode Of Treatment

The treatment will comprise of a suitable, residual spray in the external perimeter to arrest the ingress of insects, pests in to the establishment & also spray inside the rooms specially in all nooks & corners likely to harbour the pest. After the spraying it is advised to to shut the doors & windows atleast for 2 hrs. to get the desired result.


Treatment against rats, mice and bandicoots ;

Various species of rodents have different behaviour patterns, are very active at different times of the day/ night and are carriers of various pathogens causing diseases like Leptosirosis, Salmonellosis, Plague, Typhus fever, Trichinosis etc. Their active presence in human dwellings in general heightens the danger of contamination and infection.

The calls for a thorough knowledge of rodent behaviour, rodenticides and their proper use in a planned manner by highly trained and experienced technical personnel.

Our treatment primarily calls for the use of a relatively safe and highly effective single dose anticoagulant rodenticide “ROBIN” (active ingredient ‘BROMADIOLONE’ – manufactured exclusively by us in India and certified internationally as the best rodenticide in use) . Bromadiolone does not have the disadvantages that the other rodenticides have such as prebaiting, secondary poisoning and bait shyness. Our product is in the form of weather-proff wax blocas highly attractive and platable to rodents.

Mode of Treatment

The treatment would commence with strategic placement of bait to bring the infestation under control. Subsequently, We will be paying fortnightly visits to continue the baiting and keep a constant vigil on rodent population.

In addition to above, we would also be resorting to trapping, use of glue boards and treating of burrows if any, wherever found necessary.


Besides the common packing material pest like, Silver fish and fire brats, the most common pest found in Psocids. Psocids or book lice are tiny insects which are considered as a pest because their presence in or alongwith packing material contaminate the product.

The treatment comprises or proplyactic treatment with a suitable formulation followed by fogging with a thermo fogger. The fog reaches in cracks and crevices and other vulnerable places where liquid formulation sprays cannot reach.


This treatment is a judicious blend of three ingredients that posses a broad spectrum of anti-microbial activity. It is blended in a right proportianto enhance the microbicidal efficacy of the formulation chemically the constituents possess aldehyde. Alcohol and glycols which are released in the area to be treated in the form of dense fog. This treatment has been recommended to destroy gram+ve and gram-ve bacterias, moulds and viruses.

The treatment also comprises of treating the open sufface including walls and floor with liquid disinfectans. Fogging is done to control air born infection. All ventilations, exhausts, A/C ducts etc. will be clossed prior to treatment.

After the treatment premises are to be kept close for minimum 6 to 7 hours to enable the chemical to have desired effect. This is curative treatment. The efficacy of this can be judged by taking air counts ( by Haffkine Ajintha Pharmaceuticals Ltd. ) before and after the treatment.

NOTE : Material safety data sheet adopted by pest control of India. For crawling insects pest & rodents ( rat, mice ) are detail as follows.


Trade Name of Pesticides : Deltamethrin

Type of Action : Residual & Knockdown

Concentration used : 0.005 to 0.05

Diluent : Water Emulsifiable

Usage : Against Cockroaches, ants, houseflies, etc. treatment

in cracks &crevices & hidden places.

Toxicity : Acute oral LD 50 RAT = 5000 mg/kg.

Status of Govt. approval : Approved by central Insecticides Board Registration

Committee for used in House hold and human habitation.

Antidote : Diazepam/Atropine

Registration No. : CIR 17,44469/93 – Deltamethrin (flow ) – 124


Trade Name of Rodenticide : Roban

Active Ingredient : Bromodiolone

Concentration : 0.005%

Diluent : NIL

Toxicity : LD50 oral : Rat – 1.125 mg/kg body wt.

Mice – 1.75 mg/kg body wt.

Antidote : Intramascular administration of Vitamin k.

Status of Govt. Approval : Approved and Registered with the Central Insecticide Board Govt. of India.

Registration Nos. : CIR 8729/89 Bromodiolone / Cake – 3 - 0.005 – RB. CIR 8731/89/Bromodiolone / RB-4 dt. 20/01/1989

Area of Use : Godown, Office, Surrounding Campus.

Action of Rodenticide : Single does anticoagulant.

Mode of treatment : The treatment control rats, mice & mice &

Bandicoots, Control is achieved by integration of

following rodents control measures :(a) Baiting with single dose anti coagulant rodenticide

i.e. Bromodiolone.

b) Trapping with the help of cages & Glue Boards, wherever necessary.

c) Fumigation of Burrows, if necessary

d) Tracking powder ( Rarely used ).


Trade Name : Pyrethrum 2% extract

Chemical Name : Pyrethrins.

Concentration : 0.02%

Status of Govt. Approval : Approved for household purpose by CIB, Govt. of India under the registration No. VI-1061 (i).

Antidote : Phenobarbitona / Pentabarbitons.

Mode of Action : Contract, stomach, fumigant.

Target pest : For use as raw material in formulating insecticides

for control Of a wide range of insect pests such as mosquitoes, Cockroaches, houseflies, fleas, lice mites, ticks etc.

Toxicity : Acute Oral LLD50 (rat) – 2140 mg/kg. Acute Dermal LD50 ( rabbit ) – over 2000 mg/kg. Acute Inhalation LC50 (rat) – 3.4 mg/1 Various studies have shown that Pyrethrum has no Sensitisation potential and non carcinogenic, and dose impair Heredity and reproduction. Toxic to fish & other aquatic organisms. Blue gill sunfish LC50 – 10 ug/L


Active Ingredient : Chlorpyriphos.

Concentration : 0.05%

Status of Govt. Approval : Approved by CIB Govt. of India for external drain Treatment Under registration No. CI/113, 694/Chlorpyriphos/91 EC-297.

Antidote : Atropine

Mode of action : Contract, stomach.

Target pest : All species of cockroaches, especially in the drains and other Crawling insects pest in the drain & termite.

Toxicity : Oral – LD50

Rat (M) – 155 mg/kg.

Rat (F) – 135 mg/kg.

Dermal – LD50

Rabbit – 2000 mg/kg.

LD50 Rat (M) – 202 mg/kg.

Monday, October 5, 2009


1.0 Purpose:

The purpose of this document is to qualify new facility, in order to establish documented evidence that the facility has been designed and installed as per the approved design specifications, made operational, perform as intended and meets the requirements of national and international requirements/ guidelines for c GMP`s, safety and environment.

2.0 Reason for Establishing protocol for qualification of the facility:

Facility has been designed and constructed to facilitate manufacturing and packing of tablets, hard gelatin capsule and dry syrups formulations at Bommasandra Industrial area. Hence qualification of the facility is planned.


4.0 Scope:

This protocol is applicable for qualification of the facility of Micro labs limited, Bommasandra, Bangalore.

5.0 Validation team and responsibilities:

Engineering Department: Execution, compilation and review of data

Quality Assurance : Preparation, review and approval of the protocol

Production : Checks and Review

Quality control : Execution of the protocol.

6.0 Design Qualification (DQ):

6.1 Purpose:

The Purpose of design qualification is to ensure that all the critical aspects of cGMP’s, Product/Process requirements, safety, environment, ergonomics, statutory requirements and environment

controls have been considered in designing the new facility and the same has been complied & documented

6.2 Facility Design in brief:

Ground floor: Raw material store, Packing material store, tablet manufacturing area, capsule manufacturing area, dry syrup manufacturing area, primary packing cubicle, bulk storage area, secondary packing area, Finished goods store, washrooms, change rooms (Primary and secondary), cleaned equipment storage area, Dispensing area, purified water plant.

First floor : Quality control laboratory, Quality assurance

Service floor: Air handling systems/ utilities

7.0 Critical Attributes to be met while designing the facility:

7.1 Layout and Design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination, build up of dust or dirt and in general any adverse effect on the quality of products.

7.2 Location and surroundings:

All Measures to be considered in order to avoid risk of contamination from external environment which includes open sewage, drain, public lavatory or any factory which produces disagreeable or obnoxious odor, fumes, excessive soot, dust, smoke or chemical emissions.

7.3 Premises:

Premises shall be designed & equipped so as to afford maximum protection against the entry of rodents, crawling insects, flying insects, lizards, flies, birds & other animals.

7.3.1 The premises shall be provided with adequate working space to allow orderly & logical placement of equipments.

7.3.2 Movement of materials and personnel shall be considered while designing the facility so as to avoid any risk of mix-up, avoid possibilities of contamination, cross contamination & crisscross movements.

7.3.3 Lighting shall be given due importance in all areas within & outside the facility so as to carryout various operations with ease & comfort. Emergency lights shall be provided in corridors, process areas, Stores, packaging areas and stairs.

7.3.4 Drain pits shall be designed to prevent back flow, wherever drainage is provided, the same shall be concealed.

7.3.5 Air handling systems shall be designated to provide class 100,000 at rest in areas where product is directly exposed to environment. Air handling systems shall be dedicated to avoid possibilities of cross contamination.

7.3.6 Wood shall not be used anywhere in the production and storing area.

7.3.7 Anti-Termite treatment shall be carried out below the floor bed, flagging concrete around the building and walls within the facility.

7.3.8 Adequate areas shall be designated to allow sufficient and orderly warehousing of various categories of materials and products like starting ( raw materials ) and packing materials, intermediates, bulk and finished products, products in quarantine, released, rejected, returned or recalled.

7.3.9 Temperature & related humidity controls shall be provided for storage of empty & filled capsules. Areas for processing of capsule formulations shall also be temperature & relative humidity controlled.

7.3.10 Receiving & despatch bays shall protect materials & products from adverse weather conditions.

7.3.11 Various areas in the stores shall be clearly segregated. Any system replacing physical quarantine shall give equivalent assurance of segregation.

7.3.12 There shall be separate sampling area in the Stores with class 100,000 environment reverse LAF.

7.3.13 Segregation shall be provided for storage of rejected, recalled or returned materials or products.

7.3.14 Separate, safe & secured area shall be provided for printed packaging materials.

7.3.15 Dispensing area(s) with class 100,000 environment & reverse LAF shall be provided.

7.3.16 Production areas shall be designed to allow the production in uni-flow with logical sequence of operations.

7.3.17 Working & in process space shall be adequate to permit orderly & logical positioning of equipments & man-material movements.

7.3.18 Electrical fittings, pipe work, ventilation openings & service lines shall be designed, fixed and constructed to avoid creation of recesses. They shall be concealed. Service lines shall be identified by colors & the nature of supply & the direction of flow shall be marked/indicated.

7.3.19 Primary & secondary change rooms for gowning/degowning shall be provided.

7.3.20 Toilets shall be separate for males & females. Toilets shall not be directly connected with production or storage areas.

7.3.21 Quality control laboratory shall be independent from the production areas. Separate areas shall be provided each for physico-chemical, microbiological, instruments and packing materials testing.

7.3.22 Modular furniture shall be provided in Quality Control laboratory.

7.3.23 Sufficient & suitable storage space shall be provided for test samples, retained samples, reference standards, records etc.

7.3.24 Separate AHU shall be provided for microbiological laboratory.

7.3.25 Laboratory shall be provided with potable water & purified water for cleaning and analysis purposes.

7.3.26 Microbiological section shall have arrangements such as air locks & laminar airflow workstation.

7.3.27 Packaging lines shall be independent & adequately segregated.

7.3.28 Lighting in each area of the facility shall be adequate enough to perform activities with ease and comfort.

7.3.29 Lighting fixtures shall be of clean room type.

7.3.30 Dust extraction system to be considered in process area where generation of powder dust is expected during processing.

7.4 Floor:

7.4.1 The floor shall be hard, smooth, non-porous, washable, continuous, chip resistant and durable. There shall be no crevices, cracks or open joints in the floor, epoxy floor shall be considered in areas where product is exposed .

7.4.2 Floor to wall joint shall be coved.

7.4.3 Material used for flooring shall permit easy cleaning and shall not shred any particulate matter.

7.4.4 Vitrified tiles shall be used in toilets, in quality control laboratory and in Quality assurance.

7.5 Walls:

7.5.1 The external walls shall be cement plastered, made with table-molded bricks .

7.5.2 The internal partition walls shall be made with cement concrete blocks, cement plastered and painted to smooth finish, anti-static, anti-fungal and avoid flaking.

7.5.3 Internal walls shall be non-porous, smooth and washable. Corners shall be rounded, no crevices or recesses or protrusions or joints, chip resistant and minimum seams.

7.6 Ceiling:

7.6.1 The ceiling shall be hard, non porous, smooth, cleanable and chip resistant.

7.6.2 False ceiling wherever considered shall be made up of Gypsum Board, painted with polyurethane paint / Emulsion paint.

7.6.3 The wall to ceiling joints shall be coved.

7.7 Paint:

7.7.1 Polyurethane / Emulsion paint over the primer.

7.8 Doors and View panels:

7.8.1 The doors shall be non-porous, smooth, cleanable and flushed with its view panel.

7.8.2 The doors shall be polyurethane coated.

7.8.3 Double glass sealed view panels.

7.8.4 Doors shall open on the same side of the airflow.

7.9 Utilities to be provided:

7.9.1 Air handling units ( Re-circulatory, once through and ventilation).

7.9.2 Purified water system with distribution network in the form of loop.

7.9.3 Compressed air system with distribution network.

7.9.4 Steam

7.9.5 Chilled water

7.9.6 Effluent treatment plant

7.9.7 Power generator backup

7.9.8 Dust extractors in areas where powder dust is generated.

7.10 Electrical requirements:

7.10.1 Single phase & three phase electrical points shall be provided in the facility as per design requirements.

7.10.2 Critical areas and critical equipments shall have back up system in the event of power failure.

7.10.3 Earthling shall be provided to all the points.

7.10.4 Electric wiring shall be concealed.

Flame proof wherever required to be provided.

7.10.5 The lighting units are scientifically apportioned so as to provide adequate light

for the area in which they are used.

7.10.6 Light fixtures shall be accessible to allow proper maintenance, cleaning & to prevent accumulation of dust or foreign matter.

7.11 Safety aspects:

7.11.1 Emergency exits

7.11.2 Smoke detectors

7.11.3 Fire extinguishers.

7.11.4 Easy access to first aid kit.

7.11.5 Camera system.

7.11.6 Solvent storage complying the local statutory regulations.

7.11.7 Round the clock security for the premises

7.12 Regulatory Requirements

(Necessary approvals shall be obtained from following government agencies)

7.12.1 Industrial development corporation, Karnataka.

7.12.2 State electricity board

7.12.3 State pollution control board

7.12.4 Factory inspectorate.

7.12.5 Food and drugs administration, Karnataka.

7.13 Equipments:

7.13.1 cGMP complied process equipments are provided to prevent cross contamination.

7.13.2 Automated material handling systems to minimize manual handling. 8.0 Design specification: (Room/Section wise):

Design specifications in minute details shall be finalized for each room/section of the Facility .Design Requirements with respect to following points shall be finalized & enclosed to this protocol

8.1 Room Dimensions (L x B x H).

8.2 Area in Sq. feet.

8.3 Floor.

8.4 Coving.

8.5 Walls.

8.6 Doors.

8.7 Door closure.

8.8 Vision panels.

8.9 Ceiling/ False ceiling.

8.10 Paint.

8.11 Electrical fittings, lighting fixtures.

8.12 Drainage.

8.13 Utilities Points.

8.14 Air inlet/ Return grills

8.15 Machine

8.16 Temperature

8.17 Humidity

8.18 Pressure differential

8.19 HVAC

8.20 Water system

8.21 Area Qualification ( AQ):

a) Pressure differential

b) Non- Viable particle count

c) Temperature mapping of raw material store

d) Temperature monitoring.

8.21.1 Microbial monitoring:

a) Settle plate count

b) Volumetric air sampling for viable count.

c) Swab test

d) Rinse analysis

e) Drainage swabs

9.0 Installation Qualification:

9.1 Purpose: Purpose of installation qualification is to establish documented evidence that the facility has been designed and constructed as intended and deviations, if any are justified & recorded.

9.2 Facility Layout (To Scale)

Approved layout of each floor (Ground floor, First floor and Service floor) shall be matched with the actual floor construction. Any deviation to the approved layout shall be documented, Justified and approved by corporate technical team & project head. Impact of the same shall be assessed with respect to product quality.

9.2 Facility within and outside shall be assessed with respect to compliance of cGMP’s related to location, surroundings and premises.

9.3 Room data sheets: Refer design requirements of each room/ area/section. Verify the compliance & record. Any deviation shall be documented, discussed & approved incase it is concluded that the deviation shall have no impact directly or indirectly on the product quality. If otherwise, required actions shall be taken & documented.

9.4 Termite treatment certificate, FDA license to manufacture drug products in the new facility, approved layouts (Floor wise), certificates from various contractors (civil, electrical) and from various government agencies shall be attached to installation qualification report.

9.5 Changes made in the facility layouts since the start of construction of the facility shall be documented, giving justification for each change made in the layout or design specifications.

9.6 Acceptance Criteria:

The facility shall meet approved design requirements and floor layouts. Any change in the approved design or layout shall be through change control and documented. Deviations if any shall be justified, assessed, approved and documented.

10.0 Operational qualification:

Every room/ section on each floor shall be checked for flawless and smooth functioning of the following as applicable. Any discrepancy shall be identified, corrected and documented.

10.1 Opening of the doors.

10.2 Closing of the doors.

10.3 Door locks (Lock & Unlock)

10.4 Door handles & hinges

10.5 Door closure.

10.6 Light source & fixtures.

10.7 Electric points & their earthling.

10.8 Water points.

10.9 Compressed air use points.

10.10 Air Handling Unit.

10.11 Differential pressure.

10.12 Drain Points.

10.13 Acceptance Criteria:

Intended out put of the above features shall be met for each room/section as applicable.


Performance Qualification of various support services provided in each room are detailed in the respective utility protocols

12.0 Requalification criteria:

12.1 Any change/ modification is made in the facility design or layout. The affected area shall be requalified and the room data sheet of the affected area shall be updated to incorporate the change(s) made.

12.2 Any change made in the existing area support services or new or additional features are added to the room.

13.0 Discussions & Summary:

Data collected during the execution of this protocol shall be compiled and evaluated and discussed. Summary report shall be prepared.

14.0 Conclusions and final approvals:

From the data compiled, a summary report shall be prepared. Corporate technical team shall review and approve the final summary report prior to handling of the building for regular use.

15.0 Attachments:

Approved drawings

Door specifications