SOP for Sampling and Testing of Pivotal Batches – Capsule

sampling and testing records and reports.

Procedure

1. Preparation:
   • Ensure all necessary equipment and materials are available and calibrated (e.g., sampling tools, testing instruments).
   • Verify that the batch records and specifications are complete and accurate.
   • Wear appropriate personal protective equipment (PPE) and follow GMP guidelines.
2. Sampling:
   • Identify
     

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     the sampling points and quantities based on the batch size and regulatory requirements.
   • Collect samples from different stages of the production process to ensure representativeness:
     • Beginning of the batch
     • Middle of the batch
     • End of the batch
   • Use clean and sterilized sampling tools to avoid contamination.
   • Label each sample accurately with batch number, sampling point, date, and time.
   • Document the sampling process in the batch record.
3. Testing:
   • Perform the following tests on the collected samples:
     • Appearance: Visual inspection for uniformity and defects.
     • Assay: Quantification of the active pharmaceutical ingredient (API).
     • Uniformity of Dosage Units: Ensure each capsule contains the correct amount of API.
     • Dissolution: Measure the rate and extent of API release.
     • Moisture Content: Determine the water content in the capsules.
     • Microbial Limits: Check for microbial contamination.
     • Hardness and Friability: Assess the mechanical strength of the capsules.
   • Record all test results in the QC laboratory notebook or electronic system.
   • Compare the results with pre-established acceptance criteria and document any deviations.
4. Data Analysis:
   • Analyze the test results to ensure compliance with the specifications and regulatory requirements.
   • Investigate any out-of-specification (OOS) results and document the findings.
   • Summarize the results and conclusions in a detailed report.
5. Documentation:
   • Ensure all sampling and testing data are accurately recorded and signed by the responsible personnel.
   • Maintain records of the sampling and testing process, including raw data, test results, and reports.
   • Submit the documentation to the QA Team for review and approval.
6. Record Keeping:
   • Store all records in a centralized location for easy access and review.
   • Ensure electronic data is backed up regularly and securely stored.
   • Archive records according to the facility’s document retention policy and regulatory requirements.

Abbreviations Used

• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practice
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• OOS: Out of Specification

Documents

• Batch Records
• QC Laboratory Notebooks
• Testing Instruments Calibration Records
• Sampling and Testing Reports

References

• ICH Guidelines for Stability Testing
• Pharmacopeia Methods (USP, EP, etc.)

SOP Version

Version 1.0 – Effective Date: [Insert Date]