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Standard Operating Procedure (SOP) for the sampling/collection of trial, in-process, Finished product, micro, hold time, validation, control, and stability sample.

SOP for Drug Product Sampling

1.0   PURPOSE:

• • To define the procedure for the sampling of trial, in-process, finish, micro, hold time, validation, control, and stability sample.

2.0   SCOPE:

• • This SOP is applicable for the collection of trial, in-process, finish, micro, hold time, validation, control, and stability sample, manufactured at the pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • SOP for Control Sample Management. <SOP>

• • Handling of Product Hold Time. <SOP>

• • SOP for Sampling procedure for withdrawal of Stability samples. <SOP>

4.0   RESPONSIBILITY – SAMPLING PROCEDURE:

• • Production Department:

• • To intimate QA person for the sampling of drug products.

• • To ensure simultaneous entries in the sampling log register.

  • Quality Assurance:

• • To collect samples as per SOP.

• • Quality Assurance Head:

• • To provide training to the concern before the implementation of SOP.

• • Ensure the implementation of SOP.

• • To review and approve the SOP.

5.0   ABBREVIATIONS – SAMPLING PROCEDURE:

• • AQL: Acceptable Quality Level

• • Wt. : Average Weight

• • QA: Quality Assurance

• • QC: Quality Control

• • SOP: Standard Operating Procedure

• • DEFINITION:

• • Sample: Sample is concerned with the selection of a subset of individuals from within a statistical population/batch to represent characteristics of the whole population/batch.

• • Sampling: The procedure of random collection of samples from a defined location.

• • Sampling rod: Device through which sampling to be done.

7.0   PROCEDURE OF SAMPLING:

• • General Sampling Procedure

• • On completion of granulation (Blending/compression/coating/capsulation operation, concerning section’s production person, shall intimate QA through duly filled sampling log register (Annexure-1) and analysis intimation slip (Annexure-2) for sampling of drug products.

• • The QA person shall verify the analysis intimation slip against BMR for the correctness of all the details provided.

• • After verification of the details, the QA person shall fill the analysis intimation slip and prepare the sample for analysis/analysis for in-process label (Annexure-3) for the sample container.

• • The QA person shall do a sampling of the drug product as per the below-mentioned procedure and shall keep the sample in a duly labelled sample container.

• • The sample container shall be kept in self-sealing transparent polyethylene bags.

• • In the case of light-sensitive products, sample container shall be kept in self-sealing black polyethylene bags.

• • In the case of a moisture-sensitive product sample, the QA person shall keep a silica gel bag between the polyethylene bag and the sample container.

• • Sample intimation numbering shall be done as XXX/YY/NNNN,

• • Where

• • • XXX denotes manufacturing section code

• • • YY denotes the current year

• • • NNN denotes of sample intimation number.

• • The sampling of Trial, in-process, Finished, Hold time, Validation, Micro, Control, and Stability Sample:

• • Samples of blend shall be withdrawn from each drum and a composite sample shall be prepared.

• • Samples of each drum shall be mixed together to get a composite sample.

• • The pooled sample shall be withdrawn in equal quantity from each selected container as per the AQL procedure for uncoated tablets and capsules.

• • Each collected tablet/capsule shall be checked for quality attribute specified as per AQL.

• • In the case of coated tablets, once the coating is completed (% weight gain is ensured), sampling shall be done from four corners and centre of bed from the coating pan.

• • In case tablets are unloaded from the coating pan, sampling can be done from each selected containers as per AQL procedure.

• • If the coating of a batch is done in more than one lot, samples of each lot shall be mixed together to get a composite sample.

• • In the case of control sample/stability sample sampling, finished tablets/capsules shall be collected from the initial, middle, and end cycle.

• • Validation and hold time samples to be collected as per the given protocol.

• • In case if, hold time exceeds of granules/ uncoated tablet/coated tablet/capsule as per BMR, then sampling to be done from each drum in equal quantity.

• • The stability sample shall be collected as per the stability test request form given to QC.

• • The quantity of sample required, at a different stage of operation is mention below:

• • Quantity for Sampling :

• Note: Sample quantity to be collected as per the above table or it may vary as per product specification.

8.0   ANNEXURES FOR DRUG PRODUCT SAMPLING:

Annexure-1: Sampling Log Register

Annexure-2: Analysis of Intimation Slip

Annexure-3: Sample for Analysis

Annexure-4: Sample for In-Process Label