Standard Operating Procedure for Batch Sampling and Testing

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the systematic and controlled sampling and testing of batches in the pharmaceutical manufacturing process. This SOP ensures that representative samples are collected and tested for quality attributes, ensuring that the batch meets the required specifications before release for further processing or distribution.

2. Scope

This SOP applies to all personnel involved in the batch sampling and testing process, including quality control personnel, production operators, and quality assurance staff.

3. Responsibilities

• Quality Control (QC) Personnel: Responsible for performing batch sampling and testing as per approved procedures and documenting the results accurately.
• Production Operators: Responsible for assisting in the sampling process and providing the required samples to the QC department.
• Quality Assurance (QA) Department: Responsible for overseeing the batch sampling and testing process and ensuring compliance with this SOP.
• Regulatory Affairs: Responsible for verifying that all required regulatory samples are collected and documented as per regulatory requirements.

4. Procedure

4.1 Sampling Plan:

• Develop a sampling plan that defines the number of samples to be collected, sampling locations, and the frequency of sampling.
• Ensure that the sampling plan follows approved procedures and is based on statistical principles to achieve representative samples.
• Document the sampling plan and obtain approval from the QA department before implementation.

4.2 Batch Sampling:

• Before sampling, clean and prepare the sampling containers or vessels to avoid cross-contamination.
• Follow the approved sampling plan to collect samples from the specified locations within the batch.
• Use appropriate sampling techniques, such as random sampling or stratified sampling, as per the sampling plan.
• Record the sampling details, including the date, time, location, and operator’s name, in the batch sampling log.

4.3 Sample Testing:

• Transfer the collected samples to the QC laboratory for testing as per the approved testing methods and specifications.
• Perform all required tests, inspections, and measurements on the samples, ensuring adherence to the defined test procedures.
• Use calibrated and validated testing equipment for accurate and reliable test results.
• Document the test results and observations in the batch testing records.

4.4 Sample Retention:

• After testing, retain a portion of the samples as per the sample retention policy for future reference or further investigations, if needed.
• Store the retained samples in a secure and controlled environment with proper labeling and traceability.
• Dispose of the retained samples according to the sample retention policy and regulatory guidelines.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6. Documents

The following documents are relevant to this SOP:

• Batch Sampling Plan
• Batch Sampling Log
• Batch Testing Records
• Sample Retention Policy

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Batch Sampling and Testing, effective as of [Insert Date].