Standard Operating Procedure for Sampling and Retention of Samples

Purpose

The purpose of this SOP is to establish procedures for the systematic and accurate sampling of raw materials, in-process materials, and finished products, as well as the retention of representative samples for further analysis and future reference.

Scope

This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance of pharmaceutical products, including operators, technicians, and quality control personnel.

Responsibilities

• Operators: Responsible for executing procedures related to the sampling of materials during manufacturing processes.
• Quality Control Personnel: Responsible for performing sampling, conducting analysis, and retaining samples for future reference.
• Quality Assurance Personnel: Responsible for reviewing and approving sampling procedures and ensuring compliance.

Procedure

1. Follow approved sampling plans for raw materials, in-process materials, and finished products.
2. Use appropriate sampling tools and containers to collect representative samples.
3. Document sampling details, including batch or lot numbers, sampling locations, and sampling dates, in the designated logbook or electronic system.
4. Ensure that sampling is conducted at various points in the manufacturing process to capture variability.
5. For finished products, follow approved sampling plans to collect samples for release testing and future reference.
6. Transfer samples to the designated storage area promptly after collection to prevent contamination or degradation.
7. Clearly label sample containers with relevant information, including product identification, sampling date, and sampling location.
8. Retain samples for the specified retention period as per regulatory requirements and organizational policies.
9. For retained samples, conduct periodic checks to ensure stability and suitability for future reference.
10. If deviations or discrepancies are identified during sampling or retention, document and investigate the root cause.
11. Implement corrective actions based on the findings of the investigation to prevent the recurrence of sampling or retention issues.
12. Archive sampling and retention records in accordance with established retention policies.
13. Regularly review and update sampling and retention procedures based on industry standards or process changes.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Sampling Logbook
• Retention Logbook
• Deviation and Corrective Action Logs

Reference

ICH Q2(R1) – Validation of Analytical Procedures

SOP Version

Version 1.0