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SOP for Sampling Plan of Raw Materials

OBJECTIVE
To lay down a procedure for Sampling plan of raw materials.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
The Quality Control Chemist is responsible for implementation of the process.
The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE
Introduction:
  • There is one sampling plan that can be followed for all the materials. Different sampling plan were adopted for liquid and solid materials. Samples are selected in such a way that they should represent the whole bulk of the material as closely as possible.

General observation:
  • Before the start of sampling observe the container for any damage, cleanliness and labeling details. Before opening the container check for the sealing and also for any special precautions to be taken while handling the chemical.


Sampling:
  • This must be done in the sampling room.
  • Each batch is sampled using a sampling rod.
  • Different containers of the same batch are transferred into the sampling room and put on pullets and thereafter they are opened.
  • Samples from each drum of the same batch are obtained by dipping the sampling rod into the drum/barrel and samples pulled and put into separate sampling bags and clearly labeling the drum/bag.
  • A maximum of 2gm sample should be withdrawn from each drum form the total supplied number of drum/bags.
  • The sampled drums/bags should be properly closed and returned to the quarantine area bearing the labels of under test and sampled and should be kept in quarantine area until quality control department gives passing or rejection.
  • After sampling the rod is thoroughly cleaned and dried before sampling the next batch. When the rod is not in use it should be kept clean and wrapped in polythene bags. After sampling a particular batch the sampling room is thoroughly cleaned before the next batch / product is brought in.
  • The selected containers for sampling shall be cleaned where necessary, by appropriate means.
  • The containers shall be opened, sampled and resealed in a manner so as to prevent contamination.
  • Collected samples shall be labeled appropriately with the following details
  1. Name of the Material
  2. Lot / Batch Number
  3. Container identification numbers if any
  4. Date of Sampling
  5. Name of the person who collected the sample.
  • The containers from which samples have been taken shall be marked to show that samples have been removed from them.
  • For any single material, samples from various containers are put in separate sampling bags for testing. The quantity of sample withdraw which is a total of 30gm is sufficient for full analysis out of which the reminder is kept as control sample.
  • Sampling shall be done by the Laboratory Assistants / Chemists.
  • Control samples after being clearly labeled shall be stored in the control sample room.

Sampling plan
  • Number of Containers / Drums ≤ 20 100 % sampling (in which identification only is done on each of the 20 drums sampled and composite sampled for complete analysis).
  • Number of Containers / Drums > 20 Divide the drums into lots of 20 and sample all follow the same procedure 5.4.1
  • For excipients. The formula √n + 1 applies: Identification tests are performed on the percentages specified above and a composite sample is obtained on which all the test parameters are performed. Here the ‘n’ means number of containers.

Sampling Equipment: 
Spatulas, Spoons or Sample Tubes are used in case of solids and long handle cylindrical scoops for liquids.

Observations before sampling:
Solids: Check for any variation in colour appearance in different levels, any uncharacteristic odour or extraneous matter.
Liquids: Presence of suspended matter or sediment or any different layer.

REFERENCE(s)
Nil.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.A Quality Assurance
No. Number
Q.C Quality control
% Percentage

ANNEXURE(s)
Nil.

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