Instructions for Visually Inspecting Capsules for Defects

1) Purpose

The purpose of this SOP is to provide instructions for visually inspecting capsules for defects such as cracks, chips, or discoloration to ensure product quality.

2) Scope

This SOP applies to all capsules manufactured within the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) and Production departments are responsible for visually inspecting capsules for defects during and after the manufacturing process.

4) Procedure

1. Preparation for Inspection:
   1. Ensure that the inspection area is well-lit and clean.
   2. Provide inspectors with magnifying tools and adequate training on defect identification.
2. Conducting Visual Inspection:
   1. Inspect capsules individually or in small batches to identify any visible defects.
   2. Look for common defects such as cracks, chips, discoloration, and other physical imperfections.
   3. Set aside any defective capsules for further evaluation and documentation.
3. Documentation of Defects:
   1. Record the number and type of defects identified in the inspection logbook.
   2. Document the batch number and the date of inspection for traceability.
   3. Report any recurring defects to the QC manager for further investigation.
4. Handling Defective Capsules:
   1. Segregate defective capsules from acceptable ones to prevent mix-ups.
   2. Evaluate the extent of defects to determine if rework or rejection is necessary.
   3. Document the actions taken for defective capsules in the inspection logbook.
5. Review and Approval:
   1. The QC manager or designee must review and approve the inspection records and any actions taken for defective capsules.
   2. Ensure that all defective capsules are properly accounted for and handled according to the facility’s procedures.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Inspection Logbook, Defect Reports, and Batch Records

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0