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