Determining Sample Quantity for Stability Testing

Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for determining the number of samples required for performing stability tests to ensure adequate and representative sampling throughout the study duration.

Scope

This SOP applies to all stability studies conducted on drug substances and drug products within the pharmaceutical company’s facilities.

Responsibilities

• Stability Manager: Approve the number of samples required for stability testing and ensure they align with regulatory guidelines and study objectives.
• Stability Technicians: Implement and document the sampling process as specified in the stability protocol.
• Quality Assurance (QA) Team: Review and approve the sampling plan for accuracy and completeness.

Procedure

1. Review Stability Protocol:
   • Ensure the stability protocol specifies the number of samples required for each test interval and storage condition.
2. Determine Sampling Points:
   • Identify the time points for stability testing (e.g., 0, 3, 6, 9, 12, 18, 24 months).
   • Ensure sampling points align with regulatory guidelines and product stability profile.
3. Calculate Sample Quantity:
   • Determine the number of samples needed per time point for each batch and storage condition.
   • Consider additional samples for reserve, repeat tests, and potential OOS (Out of Specification) investigations.
4. Sample Collection:
   • Collect samples from each batch at the specified time points according to the stability protocol.
   • Ensure samples are labeled and documented properly.
5. Storage of Samples:
   • Store collected samples under the specified stability conditions until testing.
   • Ensure that storage conditions are monitored and documented.
6. Documentation:
   • Record the number of samples collected for each time point and storage condition in the stability protocol and associated logs.
   • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
7. Review and Approval:
   • Submit the sampling plan to the Stability Manager and QA Team for review and approval.
   • Make any necessary adjustments based on feedback and finalize the sampling plan.
8. Communication:
   • Communicate the finalized sampling plan to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.

Abbreviations Used

• QA: Quality Assurance
• OOS: Out of Specification
• SOP: Standard Operating Procedure

Documents

• Stability Protocol
• Sample Collection and Labeling Records
• Storage Condition Logs
• Regulatory Guidelines

References

• ICH Q1A(R2) Stability Testing of New Drug Substances and Products
• FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

SOP Version

Version 1.0 – Effective Date: [Insert Date]