1.0 OBJECTIVE:To lay down the procedure for sampling of Raw material.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 The intimation of receipt of raw material shall be received through G.R.N which shall be sent by the Store personnel.
5.2 Ensure that the Q.C. Supervisor goes for sampling with Mask, hand gloves, stainless steel spoons, Pipettes, labels, Sampling containers etc. in the sampling kit kept in QC Dept.
5.3 Get all the containers cleaned from outside.
5.4 Put on the mask and hand gloves.
5.5 Start RLAF 15 minutes before entering into sampling room.
5.6 Ensure that the name of Supplier/Manufacturer is in the approved vendor list (list is available in Q.C and Stores), if not, consult Quality Assurance Manager, who in turn will take up this matter with Stores and Purchase Department.
5.7 Bring only one batch of a particular Raw Material at a time inside a Sampling Room.
5.8 Carry out the sampling of Raw Materials in the sampling room only. However, materials which are received in more than 100 liter barrels sampling is to be done on the spot with proper care.
5.9 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).
5.10 Check the labels on the containers as per GRN received from store. If O.K. carry out 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.
For Sugar 5% of the total bags in a lot are 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.
5.11 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.
5.12 The purpose of container wise sampling is to identify 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 Sr. Q C Officer immediately on observing any difference in each container, while sampling.
5.13 Each sample container should bear a label indicating:
a) The name of the sampled material.
b) The batch or lot number.
c) The number of the container from which the sample has been taken.
d) The signature of person, who has taken the sample.
e) The date of sample.
5.14 Use sampling rod for sampling the Raw Materials received in bags and drums.
5.15 Use stainless steel spoon for sampling the Raw Materials received in small jars or bottles.
5.16 Liquids sampling should be done in amber glass bottles using Stainless steel measure rod or glass pipette.
5.17 Ensure proper closure of the sampled containers and affix the "Q.C. SAMPLED" labels on the container duly signed by the Q.C Supervisor.
5.18 Carry out sampling as per sampling plan, sampling kit to be taken from QC, all the equipment previously dried in the oven to be properly wrap with fresh polythene bag, after sampling uncleaned equipments to be again wrap in the same polythene bag and bring to QC for washing.
5.19 All the sampling equipment shall be cleaned after sampling first with water and than with hot purified water and finally with purified water. Dry the equipments in the oven and wrap in the polythene bag.
5.20 Ensure that sterile bottles are used for sampling of materials to be tested for microbial test. 5.21 Ensure that the collected samples are properly closed and labelled.
5.21 Document all the sampling details in the Sampling Register, sampling sheet and sampling log.
5.23 Bring the samples to Laboratory for analysis.
5.24.1 Containers and bags (inside) are to be checked for soiling and damage while possible.
5.24.2 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.
5.24.3 During sampling care shall be taken to avoid producing dust.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QC : Quality Control
6.3 Dept. : Department
6.4 G.R.N : Goods Receipt Note
6.5 RLAF : Reverse Laminar Air Flow
6.5 RLAF : Reverse Laminar Air Flow
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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