1) SOP for Inspecting Filled Capsules

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed instructions for inspecting filled capsules, identifying defects, and documenting results to ensure product quality and compliance with regulatory standards.

3) Scope

This SOP applies to all personnel involved in the inspection of filled capsules within the pharmaceutical manufacturing area.

4) Responsibilities

• Operators are responsible for performing the inspection of filled capsules according to this SOP.
• Supervisors are responsible for overseeing the inspection process and ensuring compliance.
• Quality Assurance (QA) personnel are responsible for verifying that the inspection procedures are followed correctly.

5) Procedure

1. Preparation
   1. Ensure the inspection area is clean and free of contaminants.
   2. Verify the availability of inspection tools (e.g., magnifying glass, light box).
   3. Check the cleanliness and readiness of the inspection equipment.
2. Inspection Process
   1. Collect a sample of filled capsules as per the sampling plan.
   2. Inspect each capsule for visual defects such as cracks, chips, discoloration, and contamination.
   3. Use appropriate inspection tools to enhance visibility if needed.
   4. Segregate defective capsules and document the type and number of defects observed.
   5. Record the inspection results in the inspection logbook or batch record.
3. Identification of Defects
   1. Classify defects into categories (e.g., critical, major, minor) based on predefined criteria.
   2. Document the classification and rationale for each defect identified.
4. Documentation and Reporting
   1. Ensure all inspection results are accurately recorded in the appropriate documentation.
   2. Report any significant findings to the supervisor and QA personnel immediately.
   3. Maintain all inspection records for traceability and compliance purposes.
5. Cleaning and Maintenance
   1. Clean the inspection area and tools after completing the inspection process.
   2. Document the cleaning process in the cleaning logbook.
   3. Perform regular maintenance checks on inspection tools and equipment.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Inspection Logbook
• Batch Record
• Cleaning Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual

9) SOP Version

Version 1.0