Contents of a Stability Protocol

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the essential components and format required for a stability protocol to ensure comprehensive and consistent documentation for stability studies.

Scope

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

Responsibilities

• Stability Manager: Ensure the stability protocol includes all required sections and is reviewed and approved.
• Stability Technicians: Prepare the stability protocol according to this SOP and submit for review.
• Quality Assurance (QA) Team: Review and approve the stability protocol for accuracy and completeness.

Procedure

1. Title Page:
   • Title of the stability study.
   • Protocol number and version.
   • Effective date and approval signatures.
2. Table of Contents:
   • List all sections and appendices with page numbers.
3. Introduction:
   • Purpose and objectives of the stability study.
   • Scope of the study, including drug substance or product name, batch numbers, and intended market.
4. Study Design:
   • Details of storage conditions (e.g., temperature, humidity) and duration for each stability condition (e.g., long-term, accelerated).
   • Number of batches and sample sizes to be tested.
5. Test Parameters:
   • List of physical, chemical, microbiological, and other relevant tests to be performed.
   • Specifications and acceptance criteria for each test.
6. Sample Handling:
   • Procedures for sample collection, labeling, and storage before testing.
   • Schedule for sample testing at defined intervals.
7. Data Collection and Reporting:
   • Methods for recording and reporting test results.
   • Criteria for evaluating data and determining stability conclusions.
8. Deviations:
   • Procedures for documenting and handling deviations from the protocol.
9. References:
   • Cite any guidelines, regulatory documents, or scientific literature referenced in the protocol.
10. Appendices:
    • Include any supplementary information such as detailed procedures, additional data, or supporting documents.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Stability Study Plan Template
• Test Method SOPs
• Sample Labeling 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]