1.0 Purpose
1.1 To describe a procedure to be followed for the sampling of raw materials in order to get “representative” sample of the total consignment for quality test to release the respective batch and storage of retention sample for future test/investigation purpose.
2.0 Scope
2.1 Sampling is a GMP requirement to assure that a batch of raw materials is suitable for its intended use. This is why sampling is very important for each incoming raw materials to confirm that the final product meets its specification and serves its intended purpose. This SOP is applicable for sampling of all incoming raw materials to be used for the manufacturing of drug products at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 It is the responsibility of trained Quality Control personnel to perform the sampling operations of all incoming raw materials. Quality Control Officer to Sr. Officer are also responsible for analyzing of all collected samples.
3.2 Head of Quality Control is responsible for approving or rejecting the respective batch of raw materials based on Quality Control result/report.
3.3 Head of Quality Assurance is responsible for SOP compliance.
4.0 Abbreviations and Definitions
4.1 SOP : Standard Operating Procedure
4.2 GRN : Goods Received Note
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Ensure proper protective clothing before sampling operation.
6.2 Ensure all sampling utensils are properly cleaned and dried.
6.3 Ensure all sampling utensils are properly cleaned and sterile in case of microbiological Sampling.
6.4 While opening and closing container special care shall be that no paint or metal splinters from the closure or the other foreign particles fall inside the container.
6.5 During sampling care shall be taken to avoid producing dust.
7.0 Procedure
7.1 The intimation of receipt of Raw material shall be received through GRN which shall be sent by the store personnel.
7.2 Ensure that the Quality Control Officer goes for sampling with mask, hand gloves, SS spoons, pipettes, labels; sampling containers etc. in the sampling kit kept in Quality Control Department.
7.3 Get all the containers cleaned from outside.
7.4 Put on the mask and hand gloves.
7.5 Start RLAF 15 minutes before entering into sampling room.
7.6 Ensure that the name of supplier/Manufacturer is in the approved vendor list (List is available in Quality Control and stores), if not, consult Quality Control In-Charge, who in turn will take up this matter with stores and purchase department.
7.7 Bring only one batch of a particular raw material at a time inside a sampling room
7.8 Carry out the sampling of raw materials in the sampling room only.
7.9 The sampling personnel shall however ensure that the surrounding environment is favorably dust free (under no circumstances, the sampling of solid material shall be done outside sampling room).
7.10 Check the labels on the container as per GRN received from store. If ok, carryout sampling as per following plan:
§ Active ingredients: Collect samples from all (100%) containers.
§ Inactive ingredients: collect samples from all (√n+1) containers except in sugar.
§ Sample quantity of Inactive ingredients may be increase or decrease depending on the amount of total quantities arrived. In case of more than 200 container, 5% of total container in a lot to be sampled.
§ Prepare a pooled sample from all the containers for chemical and microbiological analysis. Collect separately the samples from each container for carrying out identification test.
§ For hygroscopic active material, sampled to be collected from √n + 1 container initially. Just before dispensing each drum to be sampled, test for identification and then release.
7.11 Sample the raw materials of each control number in sampling bottles/in amber glass bottles for materials sensitive to moisture and light and affix labels.
7.12 The purpose of container wise sampling is to identity each container for its correct content. The simplest identification test may be carried out, which will also include physical appearance like color, odour, texture, particle size etc. Sampling analyst should report to Quality Control, In-Charge immediately on observing any difference in each container, while sampling.
7.13 Each sample container should bear a label indicating-
§ The name of the sampled material
§ The batch or lot number.
§ GRN No.& Date
§ The number of the container from which the sample has been taken.
§ The date of sample
§ The signature of person ,who has take the sample
7.14 Use sampling rod for sampling the raw materials received in bags and drums.
7.15 Use stainless steel spoon for sampling the raw materials received in small’s jars or bottles.
7.16 Liquids sampling should be done in amber glass bottles using stainless steel measure rod or glass pipette.
7.17 Collect the required quantity of samples mentioned below in attachment.
7.18 Sampled Quantity to be equally distributed for multi-container sample
7.19 Ensure proper closure of the sampled containers and affix the Quality Control “SAMPLED” label (adjacent to previously fixed QUARANTINE label) on the container duly signed by the Quality Control Supervisor.
7.20 Carryout sampling as per sampling plan. Sampling kit to be taken from Quality Control, all the equipment previously dried in the oven to be properly wrap with fresh polyethene bag, after sampling uncleaned equipment's to be again wrap in the same polythene bag and bring to Quality Control for washing.
7.21 All the sampling equipment shall be cleaned after sampling first with water and then with hot purified water and finally with purified water. Dry the equipment in the oven and wrap in the polyethene bag.
7.22 Ensure that sterile bottles are used for sampling of materials to be tested for microbial test.
7.23 Ensure that the collected samples are properly closed and labeled.
7.24 Document all the sampling details in the sampling record sheet.
7.25 Bring the samples to laboratory for analysis.
8.0 Reference Document
8.1 WHO Guidelines, volume 2, second edition.
9.0 Annexure
9.1 Annexure-I : Logbook of Raw Material Sampling
9.2 Annexure-II : Raw Material Sampling Record
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
.
11.0 Training
11.1 Head of Quality Control or his/her nominee shall give the SOP training before effective date.
