Capsule: SOP for Visual Inspection of Capsules During Packaging – V 2.0

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Capsule: SOP for Visual Inspection of Capsules During Packaging – V 2.0

Standard Operating Procedure for Visual Inspection of Capsules During Packaging

Department Capsule Packaging
SOP No. SOP/CP/204/2025
Supersedes SOP/CP/204/2022
Page No. Page 1 of 5
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for performing visual inspections of capsules during packaging to ensure that only capsules meeting quality standards are packaged and distributed.

2. Scope

This SOP applies to all visual inspection activities conducted during the capsule packaging process. It ensures that all capsules are inspected for defects such as cracks, discoloration, incorrect fill, or other physical irregularities.

3. Responsibilities

  • Packaging Operator: Responsible for performing visual inspections of capsules during packaging and reporting defects.
  • Quality Control (QC) Team: Responsible for conducting random audits of packaged capsules, ensuring compliance with inspection standards, and providing corrective actions when necessary.
  • Production Supervisor: Oversees the visual inspection process, ensures that inspectors follow the SOP, and ensures that any defects are addressed.

4. Accountability

The Production Manager is accountable for ensuring the proper implementation of visual inspection during packaging. The QC Manager ensures that the visual inspection process complies with GMP and regulatory standards.

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5. Procedure

5.1 Pre-Inspection Preparation

Before starting the visual inspection process, ensure the following:

  1. Prepare Inspection Materials

    1. Ensure that sufficient lighting is available for proper inspection. The inspection area should be clean and free of distractions that might affect the inspection process.
    2. Ensure that all inspection tools such as magnifying glasses, rulers, and light sources are available and in good working condition.
  2. Verify Capsule Details

    1. Confirm that the batch of capsules being packaged is the correct batch as per the batch production record (BPR) and packaging instructions.
  3. Check Packaging Materials

    1. Ensure that all packaging materials, including bottles, blister packs, and labels, are in good condition and meet the specified standards.

5.2 Visual Inspection Process

Follow these steps to perform the visual inspection of capsules:

  1. Start the Inspection

    1. Inspect each capsule individually for any defects such as cracks, chips, discoloration, or irregular fill volume. Ensure that no capsules are broken or malformed.
  2. Inspect the Capsules for Consistency

    1. Ensure that capsules are uniform in size, color, and shape. Check for any foreign particles or residues on the surface of the capsules.
  3. Document Defects

    1. Document any defective capsules found during inspection. Record the type of defect (e.g., cracked, discolored, incorrect fill) and the number of capsules affected.
  4. Reject Defective Capsules

    1. Remove any defective capsules from the production line immediately. Set them aside for rework or disposal, as applicable.
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5.3 Post-Inspection Activities

After completing the inspection, ensure the following:

  1. Final Inspection Check

    1. Perform a final check of the packaging line to ensure that all capsules have passed the visual inspection. Re-inspect any capsules with potential defects that were flagged during the initial inspection.
  2. Record Inspection Results

    1. Document the results of the visual inspection, including the total number of capsules inspected, the number of defective capsules found, and any corrective actions taken. Store records as per GMP requirements.
  3. Corrective Actions

    1. If a significant number of defective capsules are found, halt production and investigate the root cause. Take corrective actions as necessary to prevent further defects in the batch.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • BPR: Batch Production Record
  • USP: United States Pharmacopeia

7. Documents

  1. Annexure 1: Visual Inspection Log
  2. Annexure 2: QC Inspection Report
  3. Annexure 3: Packaging Equipment Calibration Log
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8. References

  • USP <701> – Disintegration of Tablets and Capsules
  • European Pharmacopoeia 2.9.1 – Dissolution Testing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Visual Inspection Log

Batch ID Inspection Date Number of Capsules Inspected Defective Capsules Operator Comments
Batch 016 03/02/2025 50,000 15 John Doe No other issues

Annexure 2: QC Inspection Report

Batch ID Inspection Date Defects Identified Corrective Actions Final Outcome
Batch 016 03/02/2025 Minor discoloration Removed defective capsules Approved

Annexure 3: Packaging Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Inspection Machine 703 01/02/2025 Jane Smith Calibration of camera system for capsule inspection 01/02/2026

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for visual inspection process QA Head
01/02/2025 2.0 Updated inspection process and documentation Improvement of inspection procedures QA Head
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