1) SOP for Sampling and Retention of Samples

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for taking representative samples of raw materials, in-process materials, and finished products for testing and analysis, and for retaining these samples for future reference and testing.

3) Scope

This SOP applies to all personnel involved in sampling and retaining samples within the pharmaceutical manufacturing facility.

4) Responsibilities

• Production personnel are responsible for taking samples according to this SOP.
• Quality Control (QC) personnel are responsible for analyzing the samples.
• Quality Assurance (QA) personnel are responsible for verifying that sampling and retention procedures are followed correctly.
• Supervisors are responsible for overseeing the sampling and retention process and ensuring compliance with this SOP.

5) Procedure

1. Preparation for Sampling
   1. Ensure that all sampling tools and containers are clean, sterilized (if necessary), and ready for use.
   2. Review the sampling plan and sampling instructions for the specific material or product to be sampled.
   3. Wear appropriate personal protective equipment (PPE) as specified in the sampling SOP.
2. Sampling Procedure
   1. Identify the sampling points and ensure that the environment is suitable for sampling to avoid contamination.
   2. Collect the sample using the appropriate method (e.g., scoop, pipette, etc.) and ensure the sample is representative of the batch.
   3. For raw materials, take samples from different locations within the container (top, middle, bottom) to ensure homogeneity.
   4. For in-process materials and finished products, follow the sampling plan to collect the required amount of sample.
   5. Label the sample containers with all necessary information, including the batch number, date, and time of sampling.
   6. Record the sampling details in the sampling logbook.
3. Retention of Samples
   1. Store the retained samples in a designated area with controlled conditions as specified (e.g., temperature, humidity).
   2. Ensure that retained samples are properly labeled with batch number, sampling date, and storage conditions.
   3. Document the storage location and conditions in the sample retention logbook.
   4. Retain the samples for a period as specified by regulatory requirements or company policy (e.g., shelf life plus one year).
   5. Conduct periodic inspections of the retained samples to ensure they remain in good condition.
4. Analysis of Samples
   1. Submit the collected samples to the QC laboratory for analysis according to the testing protocols.
   2. Document the analysis results in the laboratory logbook and compare them against the acceptance criteria.
   3. Report any deviations or out-of-specification results to the QA department for further investigation.
5. Disposal of Samples
   1. After the retention period has expired, dispose of the samples according to the company’s waste disposal procedures.
   2. Document the disposal of samples in the sample retention logbook.
   3. Ensure that the disposal process complies with environmental and safety regulations.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7) Documents, if any

• Sampling Logbook
• Sample Retention Logbook
• Laboratory Logbook
• Testing Protocols

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific sampling and retention guidelines

9) SOP Version

Version 1.0