and ensure accurate documentation and compliance.

Procedure

1. Preparation:
   • Review the stability protocol to understand the specific stress conditions required (e.g., heat, light, humidity, oxidative, acidic, and basic conditions).
   • Ensure all necessary equipment and reagents are available and calibrated.
2. Sample Collection:
   • Collect an appropriate amount of the bulk drug substance for
     

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     stress testing.
   • Document the batch number, quantity, and initial characterization data of the sample.
3. Conduct Stress Tests:
   • Thermal Stress:
     • Expose samples to elevated temperatures (e.g., 50°C, 60°C) for a specified duration.
     • Document temperature and exposure time.
   • Photolytic Stress:
     • Expose samples to intense light sources (e.g., UV, visible light) for a specified duration.
     • Document light intensity and exposure time.
   • Humidity Stress:
     • Expose samples to high humidity conditions (e.g., 75% RH, 90% RH) for a specified duration.
     • Document humidity levels and exposure time.
   • Oxidative Stress:
     • Treat samples with oxidizing agents (e.g., hydrogen peroxide) for a specified duration.
     • Document concentration of oxidizing agent and exposure time.
   • Acidic Stress:
     • Treat samples with acidic solutions (e.g., 0.1N HCl) for a specified duration.
     • Document concentration of acid and exposure time.
   • Basic Stress:
     • Treat samples with basic solutions (e.g., 0.1N NaOH) for a specified duration.
     • Document concentration of base and exposure time.
4. Sample Analysis:
   • Analyze stressed samples using appropriate analytical techniques (e.g., HPLC, GC, MS).
   • Identify and quantify degradation products.
   • Compare results with unstressed control samples.
5. Documentation:
   • Record all stress test conditions, observations, and analytical data in the stability protocol and associated logs.
   • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
6. Data Review and Interpretation:
   • Interpret the results to determine degradation pathways and potential degradation products.
   • Assess the stability of the bulk drug substance under each stress condition.
7. Review and Approval:
   • Submit the stress testing results and data interpretation to the Stability Manager and QA Team for review and approval.
   • Make any necessary adjustments based on feedback and finalize the stress testing report.
8. Communication:
   • Communicate the finalized stress testing procedures and results to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.

Abbreviations Used

• QA: Quality Assurance
• RH: Relative Humidity
• SOP: Standard Operating Procedure
• HPLC: High-Performance Liquid Chromatography
• GC: Gas Chromatography
• MS: Mass Spectrometry

Documents

• Stability Protocol
• Analytical Method SOPs
• Stress Testing Logs
• Calibration and Validation Records
• 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]