Establishing With-drawal dates for Stability Study sample

Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for determining the ‘due dates’ for various milestones in a stability study protocol to ensure timely completion and regulatory compliance.

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 ‘due dates’ for the stability study and ensure they align with the overall project timeline.
• Stability Technicians: Document the ‘due dates’ and adhere to the established timeline.
• Quality Assurance (QA) Team: Verify that the ‘due dates’ are realistic and ensure compliance with regulatory requirements.

Procedure

1. Review Stability Protocol:
   • Ensure the stability protocol includes a detailed schedule with predefined milestones and activities.
2. Identify Key Milestones:
   • List all critical milestones in the stability study, such as sample collection, testing intervals, data review, and final reporting.
3. Define Timeframes for Testing Intervals:
   • Establish testing intervals based on regulatory guidelines and the specific requirements of the stability study (e.g., 1 month, 3 months, 6 months, 12 months).
4. Calculate Due Dates:
   • Determine the ‘start date’ of the stability study as per SOP for setting the ‘start date’.
   • Calculate ‘due dates’ for each testing interval from the ‘start date’.
   • Ensure sufficient time for sample analysis, data review, and reporting at each interval.
5. Document Due Dates:
   • Record all ‘due dates’ in the stability protocol and associated logs.
   • Update any project management tools or calendars to reflect these ‘due dates’.
6. Review and Approval:
   • Submit the calculated ‘due dates’ to the Stability Manager and QA Team for review and approval.
   • Make any necessary adjustments based on feedback and finalize the ‘due dates’.
7. Communication:
   • Communicate the finalized ‘due dates’ to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
   • Ensure all team members are aware of their responsibilities and deadlines.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Stability Protocol
• Testing Interval Schedule
• Project Management Tools/Calendars

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]