Standard Operating Procedure for Stability Study Sampling Plan Execution

Purpose

The purpose of this SOP is to establish procedures for the execution of the sampling plan in stability studies conducted in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the collection and management of stability study samples.

Responsibilities

• Quality Assurance: Responsible for oversight and approval of the stability study sampling plan execution.
• Quality Control: Responsible for the actual collection of stability study samples.
• Documentation Team: Responsible for recording and managing sample collection data.

Procedure

1. Review the approved Stability Study Protocol and Sampling Plan before initiating sample collection.
2. Verify that stability chambers or storage units are operating within specified conditions before starting sample collection.
3. Collect samples at designated time points according to the approved Sampling Plan.
4. Record relevant information for each sample, including Sample ID, Batch Number, Date of Collection, and Storage Conditions.
5. Handle samples with care to avoid contamination or degradation during the collection process.
6. Transport collected samples to the designated storage area promptly, ensuring maintenance of appropriate storage conditions.
7. Document any deviations from the Sampling Plan and report them to the Quality Assurance department.
8. Regularly update the sample inventory to reflect the current status and location of each sample.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Stability Study Protocol
• Approved Sampling Plan
• Sample Collection Record
• Sample Inventory Log

Reference

No