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

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

Standard Operating Procedure for Visual Inspection of Capsules During Production

Department Capsule Manufacturing
SOP No. SOP/CM/065/2025
Supersedes SOP/CM/065/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for performing visual inspection of capsules during production to ensure that they meet the required quality standards. This is critical for identifying defects such as cracks, improper sealing, or contamination before the capsules are released for further processing.

2. Scope

This SOP applies to all capsules produced within the manufacturing facility. It covers the visual inspection process of capsules during production to ensure that they meet the necessary specifications for quality, integrity, and appearance.

3. Responsibilities

  • Manufacturing Team: Responsible for performing the visual inspection of capsules, following the procedures outlined in this SOP, and segregating defective capsules.
  • Quality Control (QC) Team: Responsible for overseeing the visual inspection process, ensuring compliance with quality standards, and verifying that all identified defects are recorded and addressed.
  • Quality Assurance (QA) Team: Ensures that the SOP is followed during capsule production and inspects the documentation for compliance with GMP standards.
  • Maintenance Team: Responsible for ensuring that the visual inspection equipment, such as inspection cameras or lights, is properly maintained and functioning.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the visual inspection process is carried out effectively. The QA Manager is responsible for reviewing the inspection records and ensuring that all deviations are appropriately addressed and documented.

5. Procedure

5.1 Pre-Inspection Preparation

Before starting the inspection process, ensure the following steps are completed:

  1. Equipment Setup

    1. Ensure that the visual inspection area is well-lit and free from any obstructions that may hinder the inspection process.
    2. Verify that inspection equipment, such as cameras or magnification tools, is calibrated and in good working condition. Clean the equipment before use to prevent contamination.
  2. Material and Capsule Preparation

    1. Ensure that the capsule shells are properly formed and free from any physical damage or deformities before beginning the filling process.
    2. Prepare the capsules for inspection by transferring them to the inspection station, ensuring that they are handled properly to avoid contamination.
  3. Documentation

    1. Document the batch information, including capsule size, fill material, and inspection parameters, in the batch production record.
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5.2 Visual Inspection Process

During production, the following steps should be taken to inspect the capsules visually:

  1. Continuous Monitoring

    1. Perform visual inspections on capsules during production at regular intervals to ensure they meet the required specifications. Check for defects such as cracks, dents, discoloration, improper filling, or any other visible defects.
  2. Inspection Criteria

    1. Examine each capsule for the following defects:
      • Cracks or chips on the capsule shell.
      • Uneven or incomplete filling of the capsule.
      • Missing or poorly sealed capsule halves.
      • Discoloration or contamination on the capsule surface.
  3. Defective Capsule Segregation

    1. Immediately segregate any defective capsules identified during the visual inspection. Place them in a designated area or container marked as “Rejected” to avoid cross-contamination with good capsules.
  4. Inspection Frequency

    1. Inspect a sample of capsules from each batch at the start, middle, and end of the production run to ensure consistency in quality throughout the process.

5.3 Post-Inspection Actions

After completing the visual inspection, the following actions should be taken:

  1. Defective Capsule Documentation

    1. Document the total number of defective capsules identified during the inspection, including the type of defect (e.g., cracks, underfilled capsules, etc.). Record this information in the inspection log or batch production record.
  2. Rejection and Disposal

    1. If the number of rejected capsules exceeds an acceptable threshold, stop the production process and investigate the cause. Document the reason for the rejection and take corrective actions if necessary.
    2. Dispose of defective capsules in accordance with environmental and safety regulations. If rework is possible, initiate the rework process based on the severity of the defect.
  3. Verification and Rework

    1. If the number of defective capsules is within the acceptable range, verify that the corrective actions were effective, and restart the production process. Perform further visual inspections if necessary to ensure continued product quality.
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5.4 Documentation and Record-Keeping

Document all visual inspection activities to ensure traceability and compliance:

  1. Inspection Logs

    1. Maintain a log of all visual inspections performed, including the number of capsules inspected, the number of defective capsules identified, and any corrective actions taken.
  2. Quality Control Records

    1. Ensure that QC records include details of the inspection, including the batch number, operator name, and inspection results. Any deviations from the standard should be noted, along with the corrective actions taken.
  3. Deviation Reports

    1. Document any deviations from the standard visual inspection criteria, including the cause of the defect and any steps taken to resolve the issue. Include the impact of the deviation on the production process.

5.5 Equipment Maintenance

Ensure that all visual inspection equipment is properly maintained:

  1. Routine Maintenance

    1. Perform routine maintenance on all inspection equipment, including visual inspection cameras, lighting, and magnification tools. Ensure that these tools are calibrated and free from defects.
  2. Calibration

    1. Calibrate inspection tools and equipment at regular intervals to ensure accuracy and reliability. Record all calibration activities in the equipment log.
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5.6 Training and Competency

Ensure that all operators involved in visual inspection are properly trained:

  1. Training

    1. Provide training to all manufacturing and QC personnel on the visual inspection process, including how to identify common defects and the importance of accurate inspection. Ensure that operators understand the criteria for acceptable and rejected capsules.
  2. Competency Verification

    1. Verify the competency of operators by conducting periodic assessments and providing feedback based on their inspection performance. Ensure that any deficiencies are addressed through additional training or support.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Capsule Visual Inspection Log (Annexure-1)
  2. Defective Capsule Report (Annexure-2)
  3. Calibration and Maintenance Record (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Visual Inspection Log

Batch ID Capsule Size Inspection Date Number of Capsules Inspected Defective Capsules Operator Name
Batch 001 Hard Gelatin 01/02/2025 500 10 John Doe

Annexure-2: Defective Capsule Report

Defect Type Number of Defective Capsules Corrective Action Taken
Cracked Capsules 5 Segregated for rework

Annexure-3: Calibration and Maintenance Record

Equipment ID Calibration Date Technician Calibration Results
Inspection Camera 5 01/02/2025 John Smith Within Tolerance

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated inspection criteria and reporting format Standardization QA Head
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