Capsule: SOP for Verification of Dispensed Materials by QA – V 2.0

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Capsule: SOP for Verification of Dispensed Materials by QA – V 2.0

Standard Operating Procedure for Verification of Dispensed Materials by QA

Department Capsule Manufacturing
SOP No. SOP/CM/006/2025
Supersedes SOP/CM/006/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To define the procedure for the verification of dispensed materials by the Quality Assurance (QA) team to ensure that the correct materials and quantities are used in capsule manufacturing.

2. Scope

This SOP applies to all dispensed materials used in capsule manufacturing, including APIs and excipients, and ensures that materials meet the required quality standards before being used in the formulation process.

3. Responsibilities

  • QA Personnel: Responsible for verifying the accuracy and compliance of dispensed materials with the batch records and specifications.
  • Manufacturing Personnel: Responsible for ensuring the correct dispensed materials are provided to the QA team for verification.
  • Warehouse Personnel: Responsible for transferring materials to the dispensing area and ensuring proper labeling and documentation of materials.
  • Quality Control (QC) Team: Responsible for testing and confirming the quality of the dispensed materials before they are verified by QA.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring the dispensed materials are provided to QA for verification. The QA Manager is responsible for ensuring that the verification process is carried out in compliance with regulatory standards.

5. Procedure

5.1 Preparation for Verification

Before the QA team can begin verification, ensure the following preparations are in place:

  1. Verify Documentation

    1. Check that the batch records, material labels, and certificates of analysis (CoA) for all dispensed materials are available and match the work order requirements.
    2. Ensure that the dispensed materials are properly labeled with the excipient name, batch number, and quantity.
  2. Prepare the Verification Area

    1. Ensure the verification area is clean and free from any potential cross-contamination.
    2. Ensure that the necessary tools (e.g., scales, measurement tools) are calibrated and available for verification.
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5.2 Verification of Dispensed Materials

QA performs the following verification steps to ensure the accuracy of dispensed materials:

  1. Compare Dispensed Materials with Batch Records

    1. Verify that the quantity of dispensed materials matches the work order and the batch record requirements.
    2. Check the batch number and material name to ensure that the correct excipients and APIs have been dispensed for the specified formulation.
  2. Confirm Material Identity

    1. Confirm the identity of the dispensed material by comparing the material’s labeling and documentation (e.g., CoA, supplier details) against the work order and formulation specifications.
    2. If any discrepancies are found, immediately report to the QA Manager for further investigation.
  3. Check for Contamination

    1. Ensure that the dispensed material is free from contamination and properly sealed during the dispensing process.
    2. If any signs of contamination or cross-contamination are found, the material should be quarantined and the incident recorded in the Discrepancy Report (Annexure-1).
  4. Confirm Compliance with Specifications

    1. Check the material’s quality specifications (e.g., purity, potency) against the CoA and other relevant documents.
    2. If the dispensed material does not meet the specifications, it should be rejected and documented in the Discrepancy Report (Annexure-1).

5.3 Documentation and Record-Keeping

Ensure proper documentation for all verification activities:

  1. Verification Log

    1. Document the verification of each material in the Verification Log (Annexure-2), including material name, batch number, quantity, and date of verification.
    2. Ensure that the log is signed by the QA personnel who performed the verification and that any discrepancies are clearly noted.
  2. Discrepancy Reporting

    1. If discrepancies or non-conformances are found, report them immediately in the Discrepancy Report (Annexure-1).
    2. The QA Manager will review and initiate corrective actions as necessary, which may involve reprocessing, returning the material, or rejecting the batch.
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5.4 Handling Non-Conforming or Rejected Materials

If dispensed materials do not conform to the required specifications, follow these steps:

  1. Quarantine the Material

    1. Immediately quarantine the non-conforming materials and label them as “Rejected” or “Quarantined” to prevent accidental use.
    2. Ensure that the rejected materials are segregated from approved materials in the storage area.
  2. Investigate the Issue

    1. Investigate the cause of the discrepancy and determine if it was due to dispensing errors, incorrect documentation, or contamination.
    2. Take corrective actions to resolve the issue, such as retraining personnel, improving procedures, or adjusting equipment.
  3. Corrective and Preventive Action (CAPA)

    1. Initiate corrective actions and document them in the CAPA log (Annexure-3). Follow up with preventive actions to avoid recurrence of the issue.

5.5 Final Approval and Release

Once verification is complete, the QA team takes the following actions:

  1. Approve for Use

    1. If the dispensed materials are verified to be accurate, compliant, and free from contamination, the QA team approves the materials for use in the manufacturing process.
  2. Release to Manufacturing

    1. The approved materials are transferred to the manufacturing area for use in the formulation process.
    2. Update the inventory management system to reflect the materials’ use and ensure traceability throughout the manufacturing process.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • CoA: Certificate of Analysis
  • PO: Purchase Order

7. Documents

  1. Verification Log (Annexure-2)
  2. Discrepancy Report (Annexure-1)
  3. Corrective and Preventive Action Log (Annexure-3)

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8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

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Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Discrepancy Report

Date Material Name Batch Number Issue Description Corrective Action
03/02/2025 API-123 Batch 67890 Incorrect Labeling Re-labeled and Returned to Supplier

Annexure-2: Verification Log

Date Material Name Batch Number Quantity Verified Verification Personnel Approval Status
04/02/2025 Excipient-123 Batch 112233 100 g John Doe Approved

Annexure-3: Corrective and Preventive Action Log

Date Issue Description Corrective Action Taken Preventive Action Responsible Personnel
05/02/2025 Incorrect Dispensed Quantity Retrained personnel on weighing accuracy Implemented double-check system for weighing Jane Smith

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 Document Format and Updates Standardization QA Head
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