the study intervals and climatic conditions as specified in this SOP and the stability protocol.

Quality Assurance (QA) Team: Review and approve intervals and conditions and ensure compliance with documentation standards.

Procedure

1. Determine Study Intervals:
   • Review regulatory guidelines (e.g., ICH Q1A(R2), FDA) to
     

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     determine appropriate intervals for stability testing.
   • Establish the following testing intervals:
     • Accelerated Testing: 0, 1, 3, and 6 months
     • Long-term Testing: 0, 3, 6, 9, 12, 18, and 24 months, then annually thereafter until the end of the proposed shelf life
     • Intermediate Testing (if applicable): 0, 3, 6, 9, and 12 months
2. Determine Climatic Conditions:
   • Set up storage conditions based on the climatic zones relevant to the US market:
     • Long-term Storage: 25°C ± 2°C / 60% RH ± 5% RH
     • Accelerated Storage: 40°C ± 2°C / 75% RH ± 5% RH
     • Intermediate Storage (if needed): 30°C ± 2°C / 65% RH ± 5% RH
   • Calibrate and validate storage units to ensure consistent performance.
   • Install monitoring devices (e.g., temperature and humidity sensors) in each unit.
3. Label and Organize Samples:
   • Assign each sample a unique identifier.
   • Label samples with storage conditions, study identifiers, and time points.
   • Organize samples by study, batch, and time point within the storage units.
4. Monitor Storage Conditions:
   • Regularly monitor and record storage conditions (e.g., temperature, humidity).
   • Set up alarms and alerts for deviations from specified conditions.
   • Document any deviations and corrective actions taken.
5. Document Study Intervals and Conditions:
   • Record all intervals and conditions in the stability protocol and associated logs.
   • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
6. Perform Regular Audits:
   • Conduct regular audits of storage conditions to ensure ongoing compliance.
   • Document audit findings and take corrective actions if necessary.
7. Review and Approval:
   • Submit the intervals and conditions to the Stability Manager and QA Team for review and approval.
   • Make any necessary adjustments based on feedback and finalize the study intervals and conditions.
8. Communication:
   • Communicate the finalized intervals and conditions to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.

Abbreviations Used

• QA: Quality Assurance
• RH: Relative Humidity
• SOP: Standard Operating Procedure
• ICH: International Council for Harmonisation

Documents

• Stability Protocol
• Storage Unit Calibration and Validation Records
• Storage Condition Monitoring Logs
• Audit Reports
• 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]