sampling and testing procedures and ensure adherence to regulatory standards.

Procedure

1. Preparation for Sampling:
   • Ensure all necessary sampling equipment and containers are clean and suitable for use.
   • Label sampling containers with batch information, sampling date, and storage conditions.
2. Sampling Procedure:
   • Identify the pivotal batches for sampling based on the stability
     

     “Mastering Pharmaceutical Stability Testing: Your Complete Guide to Ensuring Long-lasting Quality and Efficacy in Drug Development”

     protocol.
   • Randomly select samples from different locations within the batch to ensure representativeness.
   • Collect the required number of tablets as specified in the stability protocol.
   • Place the samples into the labeled containers, ensuring no contamination occurs.
3. Testing of Samples:
   • Perform initial testing on the samples to establish baseline data at time zero (To).
   • Conduct the following tests on the sampled tablets:
     • Appearance
     • Weight variation
     • Disintegration time
     • Dissolution profile
     • Assay of active ingredients
     • Related substances/impurities
     • Moisture content (if applicable)
   • Record all test results in the appropriate laboratory notebooks and databases.
4. Documentation:
   • Document the sampling process, including the batch number, sampling date, and sample quantities.
   • Maintain detailed records of all tests performed, including methods, results, and observations.
   • Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
5. Handling Deviations:
   • Investigate any deviations from the specified procedures or unexpected results.
   • Document the deviation, including the date, time, personnel involved, and potential impact on the study.
   • Implement corrective actions to address the root cause and prevent recurrence.
   • Record corrective actions taken and review effectiveness.
6. Quality Control:
   • Perform a final review of the sampling and testing data to ensure accuracy and completeness.
   • QA Team to conduct periodic audits of sampling and testing records for compliance.
7. Storage of Samples:
   • Store the remaining stability samples under specified conditions in stability chambers.
   • Ensure proper organization within the storage units by study, batch, and time point.

Abbreviations Used

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• To: Time Zero

Documents

• Stability Protocol
• Sampling Records
• Test Methods and Specifications
• Laboratory Notebooks
• Audit Reports

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]