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Friday, September 26, 2008

Raw Material Sampling SOP

1.0 PURPOSE :
To detail the procedure for sampling.
2.0 SCOPE :
Applicable during sampling of all Raw material active ingredients and Inactive ingredients.
3.0 RESPONSIBILITY :
All Q.C. Chemists / Officers
4.0 PROCEDURE :
4.1 :SAMPLING PLAN
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 PREPARATORY WORK :
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 SAMPLING
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.

1 comment:

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