Standard Operating Procedure for Visual Inspection of Finished Products
1) Purpose
The purpose of this SOP is to establish procedures for the visual inspection of finished pharmaceutical products to ensure they meet quality standards before release for distribution.
2) Scope
This SOP applies to all personnel involved in the visual inspection of finished products within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Quality Control (QC) Inspectors
- Conduct visual inspections according to approved procedures.
- Document inspection results accurately.
3.2 Production Supervisor
- Verify inspection results and authorize product release.
- Address any discrepancies or non-conformities found during inspection.
4) Procedure
4.1 Inspection Environment
- Conduct visual inspections in a controlled environment with adequate lighting.
- Ensure inspection area is free from distractions and contamination sources.
4.2 Inspection Criteria
- Refer to product specifications and approved visual inspection criteria.
- Inspect for defects such as discoloration, cracks, and foreign particles.
4.3 Inspection Process
- Handle finished products carefully to avoid damage or contamination.
- Use magnification or additional tools if necessary to aid inspection.
4.4 Documentation and Reporting
- Record inspection results and any deviations from acceptance criteria.
- Prepare inspection reports and obtain necessary approvals.
5) Abbreviations, if any
SOP: Standard Operating Procedure; QC: Quality Control
6) Documents, if any
- Visual Inspection Records
- Non-Conformance Reports (if applicable)
- Product Release Authorization
7) Reference, if any
USP General Chapter <790>: Visual Inspection of Injections
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
8) SOP Version
Version 1.0