and document results accurately.

Quality Assurance (QA) Team: Review and approve 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,
     

     “Unlocking the Secrets of Drug Product Stability: Ensuring Optimal Quality and Shelf Life for Safe Consumption”

     sampling date, and storage conditions.
2. Sampling Procedure:
   • Identify the pivotal batches for sampling based on the stability protocol.
   • Randomly select samples from different locations within the batch to ensure representativeness.
   • For powders, collect the required quantity using a sterile scoop or spatula and transfer into labeled containers.
   • For syrups, draw the required volume using a sterile pipette or syringe and transfer into labeled containers.
   • Ensure no contamination occurs during the sampling process.
3. Reconstitution:
   • Reconstitute powders and syrups according to the specific instructions provided in the product’s labeling.
   • Use sterile water or other specified solvent for reconstitution.
   • Mix thoroughly to ensure complete dissolution or suspension.
4. Testing of Samples:
   • Perform initial testing on the samples to establish baseline data at time zero (To).
   • Conduct the following tests on the sampled products:
     • Appearance
     • pH
     • Viscosity (for syrups)
     • Assay of active ingredients
     • Related substances/impurities
     • Microbial limit tests
     • Moisture content (for powders)
   • Record all test results in the appropriate laboratory notebooks and databases.
5. 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.
6. 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.
7. 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.
8. 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]