SOP for Determining the Commencement Date for Stability Testing

Setting the ‘Start Date’ for a Stability Study

Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for setting the ‘start date’ for a stability study to ensure consistency and compliance with regulatory requirements.

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 ‘start date’ and ensure it aligns with the study protocol and regulatory requirements.
  • Stability Technicians: Document the ‘start date’ and ensure all preparatory activities are completed before this date.
  • Quality Assurance (QA) Team: Verify that the ‘start date’ is documented correctly and all pre-study requirements are met.

Procedure

  1. Review Stability Protocol:
    • Ensure the stability protocol is finalized and approved by the Stability Manager and QA Team.
    • Confirm the protocol includes clear guidelines for setting the ‘start date’.
  2. Sample Preparation and Collection:
    • Collect samples from the designated batch(es) according to the protocol.
    • Ensure samples are labeled and documented as per the stability protocol.
  3. Completion of Preparatory Activities:
    • Verify that all stability chambers and equipment are calibrated and ready for use.
    • Ensure that all initial testing (e.g., T0 analysis) is completed and documented.
  4. Setting the ‘Start Date’:
    • The ‘start date’ should be the date when the samples are placed into the designated stability chambers under specified conditions.
    • Document the ‘start date’ in the stability protocol and all relevant logs.
    • Notify relevant stakeholders (e.g., Stability Manager, QA Team) of the ‘start date’.
  5. Documentation:
    • Record the ‘start date’ in the stability protocol, sample logs, and any other relevant documents.
    • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
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Abbreviations Used

  • QA: Quality Assurance
  • SOP: Standard Operating Procedure

Documents

  • Stability Protocol
  • Sample Collection and Labeling Records
  • Stability Chamber Calibration Records
  • Initial Testing (T0) Results

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]

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