Recording Visual Inspection Outcomes

1) Purpose

The purpose of this SOP is to outline the procedure for documenting the results of visual inspections of capsules to ensure accuracy, traceability, and compliance with regulatory standards.

2) Scope

This SOP applies to all visual inspections conducted on capsules in the pharmaceutical manufacturing facility, from production through to final packaging.

3) Responsibilities

– QC personnel are responsible for recording the visual inspection results.
– Production supervisors must ensure that inspection documentation is completed accurately and in a timely manner.
– The QA department is responsible for reviewing and maintaining inspection documentation.

4) Procedure

1. Preparation for Documentation
1.1. Ensure availability of visual inspection forms and documentation tools.
1.2. Verify that forms are current and controlled versions.
2. Documentation Process
2.1. Upon completion of the visual inspection, immediately document the results.
2.2. Include the following details on the inspection form:
2.2.1. Batch number
2.2.2. Date and time of inspection
2.2.3. Name of inspector
2.2.4. Number of capsules inspected
2.2.5. Number and type of defects observed
2.2.6. Acceptance or rejection decision
2.3. Use clear, legible handwriting or electronic entry as specified.
2.4. If defects are observed, record detailed descriptions and, if possible, attach photographic evidence.
3. Review and Approval
3.1. Submit the completed inspection form to the production supervisor for initial review.
3.2. The QA department will perform a final review and approval of the inspection documentation.
3.3. Any discrepancies or issues noted during the review should be addressed promptly.
4. Filing and Storage
4.1. File the approved visual inspection form in the batch record.
4.2. Store the batch records as per the company’s document retention policy.
5. Corrective Actions
5.1. If the batch is rejected, initiate a corrective action report.
5.2. Document all actions taken to rectify issues identified during visual inspection.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Visual Inspection Form
– Batch Record
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– EMA Guidelines on Good Manufacturing Practice

8) SOP Version

Version 1.0