Standard Operating Procedure for End of Cycle Inspection and Documentation for Lyophilization
1) Purpose
This SOP outlines the steps for inspecting the product and equipment after the lyophilization cycle is complete, and the proper documentation procedures to ensure quality and regulatory compliance.
2) Scope
This SOP applies to all operators and QA personnel involved in the inspection of lyophilized products and equipment at the end of the freeze-drying cycle.
3) Responsibilities
- Operators: Responsible for performing the inspection and documenting any deviations or issues observed during or after the cycle.
- QA Personnel: Responsible for reviewing the inspection reports and ensuring that all records are complete and accurate.
4) Procedure
4.1 Visual Inspection of Product
4.1.1 Appearance of Vials
- 4.1.1.1 Inspect each vial for signs of collapse, discoloration, or any other defects that may have occurred during the freeze-drying process.
- 4.1.1.2 Record the number of defective vials and note any patterns or abnormalities in the defects.
4.1.2 Sealing and Closure
- 4.1.2.1 Ensure that all vials have been properly sealed with their rubber stoppers fully seated and crimped, ensuring no leaks.
4.2 Equipment Inspection
4.2.1 Chamber Inspection
- 4.2.1.1 Inspect the lyophilizer chamber for any residual product, frost buildup, or contamination. Clean as necessary before the next cycle.
4.2.2 Sensor and
Instrument Calibration Check
- 4.2.2.1 Verify that all sensors (temperature, vacuum) performed within the specified range during the cycle. Record any deviations in performance.
4.3 Documentation
Complete the End of Cycle Inspection Logbook, documenting the condition of the product and equipment. Ensure that any defects or issues are addressed and signed off by both the operator and QA personnel before the release of the batch.
5) Abbreviations
- QA: Quality Assurance
6) Documents
- End of Cycle Inspection Logbook
7) References
- Pharmacopoeial guidelines for lyophilization equipment and product inspection
8) SOP Version
Version 1.0
Annexure
End of Cycle Inspection Logbook Template
| Date | Product Name | Batch No. | Inspection Findings | Number of Defective Vials | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Product Name | Batch Number | Details of Findings | Number | Operator Name | QA Initials |