Procedures for Sampling Capsules for Content Uniformity Testing

1) Purpose

The purpose of this SOP is to outline the sampling procedures for selecting capsules for content uniformity tests to ensure a representative and unbiased sample.

2) Scope

This SOP applies to the sampling of all capsules produced within the pharmaceutical manufacturing facility for content uniformity testing.

3) Responsibilities

The Quality Control (QC) department is responsible for selecting and sampling capsules for content uniformity testing.

4) Procedure

1. Sampling Plan:
   1. Develop a sampling plan that specifies the number of capsules to be sampled from each batch.
   2. Ensure the sampling plan is based on statistical methods to obtain a representative
      sample.
2. Preparation for Sampling:
   1. Ensure all sampling tools and containers are clean and properly labeled.
   2. Wear appropriate personal protective equipment (PPE).
3. Sampling Process:
   1. Randomly select capsules from different locations within the batch to avoid bias.
   2. Ensure the sample size meets the requirements specified in the sampling plan.
   3. Place the sampled capsules into labeled containers and record relevant details such as batch number and date.
4. Handling of Samples:
   1. Transfer the samples to the laboratory under suitable conditions to avoid contamination or degradation.
   2. Store the samples as per the specified conditions until they are ready for testing.
5. Documentation:
   1. Document the sampling process, including the number of samples taken and the locations within the batch.
   2. Maintain records of the sampled capsules in the sampling logbook.

5) Abbreviations, if any

PPE: Personal Protective Equipment

QC: Quality Control

6) Documents, if any

Sampling Plan, Sampling Logbook, and Sample Labels

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0