Capsule: SOP for Documentation of Capsule Defects – V 2.0

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Capsule: SOP for Documentation of Capsule Defects – V 2.0

Standard Operating Procedure for Documentation of Capsule Defects

Department Capsule Manufacturing
SOP No. SOP/CM/086/2025
Supersedes SOP/CM/086/2022
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 documenting capsule defects during production. Proper documentation of defects is essential to identify, address, and prevent recurring quality issues, and to ensure compliance with regulatory and internal quality standards.

2. Scope

This SOP applies to all defects identified during capsule manufacturing, including defects related to capsule shape, size, weight, color, and external coating. It covers the steps for identifying, documenting, and addressing capsule defects in compliance with GMP guidelines.

3. Responsibilities

  • Production Operators: Responsible for identifying and documenting any defects in capsules during production, including visual and mechanical defects.
  • Quality Control (QC) Team: Responsible for reviewing defect documentation, verifying the causes of defects, and ensuring that corrective actions are taken.
  • Quality Assurance (QA) Team: Ensures that defect documentation is completed in accordance with regulatory standards and internal policies, and reviews defect logs for compliance.
  • Production Supervisor: Oversees the defect documentation process and ensures that appropriate corrective actions are taken when defects are detected.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the defect documentation process is followed properly and that all defects are recorded accurately. The QA Manager is responsible for reviewing the defect logs and approving corrective actions.

5. Procedure

5.1 Identifying Capsule Defects

Capsules must be thoroughly inspected during the manufacturing process to identify any defects. The following steps should be taken:

  1. Visual Inspection

    1. Inspect capsules for visible defects such as cracks, discoloration, chips, or damage to the capsule shell.
    2. Examine capsules for irregularities in shape, including improper sealing or deformations.
  2. Weight Check

    1. Weigh a sample of capsules and check for any discrepancies in weight, which could indicate under or over-filling, or defects in the shell.
    2. Record weight deviations in the defect documentation log.
  3. Coating and Fill Material Check

    1. Inspect the capsules for defects in the coating, such as uneven coating, cracks, or peeling.
    2. Check for fill material leakage or underfilled capsules.
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5.2 Documenting Defects

Once a defect is identified, it must be documented in the defect log as follows:

  1. Document Defect Type

    1. Record the type of defect identified, such as cracked capsule, uneven coating, weight deviation, etc.
    2. Describe the defect in detail, including the location of the defect on the capsule, and the severity (e.g., minor, major, critical).
  2. Record Quantity of Defective Capsules

    1. Document the number of defective capsules identified during the inspection. This should include both total defective capsules and a breakdown by defect type if applicable.
  3. Record Cause (If Known)

    1. If the cause of the defect is known, document the suspected or identified cause (e.g., equipment malfunction, incorrect material, environmental factors, etc.).
  4. Record Action Taken

    1. Document any immediate corrective actions taken to address the defect, such as stopping production, adjusting equipment settings, or inspecting raw materials.
  5. Sign and Date the Log

    1. The operator responsible for identifying the defect must sign and date the defect log to ensure traceability and accountability.

5.3 Investigating the Cause of Defects

If a significant number of defects are identified, an investigation must be carried out to determine the root cause of the issue:

  1. Analyze Equipment and Machine Settings

    1. Review the settings of capsule manufacturing equipment, including capsule filling machines, banding equipment, and coating machines, to identify any potential issues.
    2. Perform calibration checks and maintenance on the equipment to ensure it is functioning properly.
  2. Review Materials Used

    1. Check the quality of raw materials used in the capsule production process. Ensure that the excipients, fill materials, and capsule shells meet the specified standards.
  3. Environmental Conditions

    1. Evaluate the environmental conditions in the production area, including temperature and humidity, to ensure that they are within the acceptable range for capsule production.
  4. Investigate Personnel or Process Issues

    1. Assess whether any personnel issues, such as inadequate training, could be contributing to the defects.
    2. Review the manufacturing process steps to ensure compliance with the SOPs and identify potential areas for improvement.
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5.4 Corrective and Preventive Actions

If the root cause of the defect is identified, corrective and preventive actions must be implemented:

  1. Corrective Actions

    1. Implement immediate corrective actions to address the defect, such as adjusting equipment settings, replacing defective materials, or performing repairs.
    2. Ensure that the defective capsules are removed from the production line and documented as part of the batch rejection process.
  2. Preventive Actions

    1. Implement preventive actions to reduce the likelihood of similar defects occurring in the future, such as updating training procedures, improving equipment calibration protocols, or revising material specifications.
  3. Monitor Effectiveness of Actions

    1. Monitor the results of the corrective and preventive actions to ensure that they are effective in eliminating defects.
    2. Continue to document and track defects to ensure that the actions taken result in long-term improvements.

5.5 Review and Reporting

Regular review of defect documentation is required to ensure continued quality control:

  1. Review Defect Logs

    1. The QA team should regularly review defect logs to identify trends, recurring issues, and areas for improvement.
    2. Prepare periodic reports summarizing the types and frequencies of defects observed, as well as actions taken.
  2. Report to Regulatory Authorities

    1. If the defect rate is unusually high or if the defects are critical in nature, report the issue to the appropriate regulatory authorities according to the reporting requirements.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good
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  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Capsule Defect Documentation Log (Annexure-2)
  3. Deviation Report (Annexure-3)
  4. Corrective and Preventive Action (CAPA) Report (Annexure-4)

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: Batch Production Record (BPR)

Batch ID Production Date Defects Found Action Taken Operator Name
Batch 001 01/02/2025 None Approved John Doe

Annexure-2: Capsule Defect Documentation Log

Defect ID Defect Description Capsules Affected Corrective Action Taken Operator Name
DEF-001 Cracked Capsule 50 Rejected and removed from line Jane Smith

Annexure-3: Deviation Report

Deviation ID Deviation Description Corrective Action Taken Approved By
DEV-001 Uneven capsule sealing Adjusted machine settings, reprocessed affected batch QA Head

Annexure-4: Corrective and Preventive Action (CAPA) Report

CAPA ID Root Cause Corrective Action Preventive Action Completion Date Approval Status
CAPA-001 Machine calibration error Recalibrated machine and retrained operators Implemented regular calibration checks 03/02/2025 Approved

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 defect identification and documentation procedures Standardization QA Head
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