Capsule: SOP for Maintaining Capsule Appearance During Packaging – V 2.0

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Capsule: SOP for Maintaining Capsule Appearance During Packaging – V 2.0

Standard Operating Procedure for Maintaining Capsule Appearance During Packaging

Department Capsule Manufacturing
SOP No. SOP/CM/100/2025
Supersedes SOP/CM/100/2022
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 process for maintaining capsule appearance during packaging. Ensuring that capsules retain their appearance throughout the packaging process is crucial for maintaining product quality, appearance, and compliance with regulatory standards.

2. Scope

This SOP applies to all capsule manufacturing processes that include the packaging of finished capsules. It covers the steps for inspecting, handling, and packaging capsules to ensure they retain their appearance, including size, shape, color, and integrity.

3. Responsibilities

  • Production Operators: Responsible for inspecting capsules during the packaging process and ensuring they meet the required appearance specifications.
  • Quality Control (QC) Team: Responsible for performing random inspections of packaged capsules and ensuring that they meet appearance and quality standards.
  • Quality Assurance (QA) Team: Ensures that the SOP is followed and that the final product complies with regulatory and appearance standards.
  • Production Supervisor: Oversees the entire packaging process, ensures compliance with the SOP, and resolves any appearance-related issues that arise during packaging.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule appearance is maintained during the packaging process. The QA Manager is responsible for reviewing the packaging results and ensuring compliance with all appearance standards.

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5. Procedure

5.1 Preparing Capsules for Packaging

Before beginning the packaging process, ensure that the following steps are completed:

  1. Inspect Capsule Appearance

    1. Inspect a sample of capsules to ensure that they meet the specified size, shape, color, and integrity requirements.
    2. Look for any defects, such as cracks, discoloration, or uneven capsule surfaces. Any capsules with appearance defects should be segregated for rejection.
  2. Ensure Proper Handling

    1. Handle capsules with care to avoid causing damage or altering their appearance. Use soft and clean surfaces for capsule handling.
    2. Ensure that the capsules are not exposed to excessive heat, humidity, or light, as these factors can affect the appearance of the capsules.

5.2 Capsule Packaging Process

Once the capsules are ready for packaging, follow these steps:

  1. Set Up Packaging Equipment

    1. Set up the packaging line, ensuring that all equipment, including the capsule filling machine, capsule inspection machine, and packaging materials, are clean and ready for use.
    2. Ensure that the packaging machine settings are adjusted to match the size and specifications of the capsules.
  2. Monitor Capsule Appearance During Packaging

    1. Monitor the appearance of capsules as they are being fed into the packaging machine. Ensure that capsules are correctly aligned, and check for any damaged or defective capsules.
    2. Inspect the final packaging for any issues related to the appearance of the capsules, such as cracked, broken, or discolored capsules.
  3. Adjust Equipment if Necessary

    1. If any defects are detected during the packaging process, stop the machine and adjust the settings. Investigate the cause of the appearance defects (e.g., machine malfunction, improper handling, or environmental factors).
    2. Recalibrate equipment or adjust the packaging speed if necessary to maintain capsule appearance.
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5.3 Capsule Quality Control and Final Inspection

Once the capsules have been packaged, perform the following quality control steps:

  1. Random Sampling

    1. Perform random sampling of packaged capsules for visual inspection. Ensure that a representative sample is selected to check for any appearance defects.
    2. Check capsules for consistency in size, color, shape, and surface integrity. Any defective capsules should be rejected and documented.
  2. Inspect Packaging Integrity

    1. Ensure that the capsules are properly sealed and that the packaging is intact. Check for any signs of contamination, damage, or tampering with the packaging.
    2. Document the inspection results, including the number of capsules inspected, any defects found, and the actions taken.
  3. Rejection of Defective Capsules

    1. If any capsules do not meet the appearance standards, they should be rejected and properly disposed of in accordance with the rejection procedure.
    2. Document the rejection in the Reject Log (Annexure-1) and investigate the cause of the defects to prevent recurrence.

5.4 Documentation and Reporting

It is essential to document all steps in the process to ensure traceability and compliance:

  1. Maintain Packaging Records

    1. Document all packaging details, including batch number, capsule specifications, packaging materials used, and inspection results in the Batch Production Record (BPR) (Annexure-2).
  2. Record Defective Capsules

    1. Record any defective capsules, including the reason for rejection and the corrective actions taken, in the Reject Log (Annexure-1).

5.5 Final Approval and Release

After completing the inspection and ensuring the capsules meet the required appearance standards, the following steps should be taken:

  1. QA Review

    1. The QA team should review all packaging and inspection records to ensure that the capsules meet the required appearance standards and are compliant with clinical trial or commercial requirements.
  2. Approval for Release

    1. If the capsules pass the final inspection and are deemed suitable for use, the batch is approved for release and packaging.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • BPR: Batch Production Record

7. Documents

  1. Batch Production Record (BPR) (Annexure-2)
  2. Reject Log (Annexure-1)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

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11. Annexures

Annexure-1: Reject Log

Batch ID Reason for Rejection Number of Rejected Capsules Corrective Action
Batch 001 Capsules with color variation 50 Recalibrated color sorting machine

Annexure-2: Batch Production Record (BPR)

Batch ID Capsule Specifications Appearance Check Rejected Capsules Corrective Actions
Batch 001 Size 0, White Pass 0 None

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 procedures for handling defective capsules and corrective actions Standardization QA Head
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