Capsule: SOP for Documenting QC Test Results for Capsules – V 2.0

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Capsule: SOP for Documenting QC Test Results for Capsules – V 2.0

Standard Operating Procedure for Documenting QC Test Results for Capsules

Department Quality Control
SOP No. SOP/QC/223/2025
Supersedes SOP/QC/223/2022
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 establish the procedure for documenting the results of Quality Control (QC) tests performed on capsules. Proper documentation ensures the integrity, traceability, and compliance of test results with regulatory and GMP requirements.

2. Scope

This SOP applies to all QC test results for capsules produced at the facility. It covers the recording, reviewing, and archiving of test results for various tests including, but not limited to, assay, dissolution, hardness, and microbial testing.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for performing all QC tests on capsules, documenting results accurately, and ensuring that all necessary details are recorded in the test logbooks or electronic systems.
  • Quality Assurance (QA) Team: Ensures that test results are reviewed and verified for compliance with specifications and regulatory standards. QA also ensures proper documentation practices are followed.
  • Records Management Team: Responsible for archiving QC test results and ensuring they are retrievable for audits and regulatory inspections.

4. Accountability

The QC Manager is accountable for overseeing the documentation of all QC test results and ensuring compliance with this SOP. The QA Manager is responsible for reviewing and approving the test result documentation.

5. Procedure

5.1 Recording QC Test Results

Follow these steps when documenting the results of QC tests on capsules:

  1. Perform QC Testing

    1. Perform the required QC tests as per the product specifications and testing protocols, including but not limited to assay, dissolution, hardness, weight variation, and microbial testing.
    2. Ensure that all testing is conducted according to validated methods and in compliance with GMP.
  2. Document Test Results

    1. Record the results of each test in the appropriate QC test logbooks or electronic record systems.
    2. Include the test parameters, method used, test conditions, and the observed results. For example, if testing for dissolution, document the time points, test conditions, and the dissolution values observed.
  3. Sign and Date Test Records

    1. Ensure that the individual performing the test signs and dates the test results to verify that they were conducted as per SOP and protocol.
    2. If the results are entered electronically, ensure that the system captures the user ID and date for traceability.
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5.2 Review of Test Results

Once test results are recorded, the following review process must be followed:

  1. Initial Review by QC Team

    1. The QC team member who performed the test must perform an initial review of the results for consistency with product specifications.
    2. If the results are within the defined limits, the QC member should proceed to submit the results for final approval. If the results are out of specification (OOS), they must be flagged for further investigation.
  2. Review by QA Team

    1. The QA team will review the documented test results for compliance with GMP and regulatory standards. This review ensures that all necessary details are present and that results are within specified limits.
    2. If any deviations or out-of-specification results are found, QA will investigate the root cause and determine the necessary corrective actions.
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5.3 Approval of Test Results

Once the results are reviewed, they must be approved as follows:

  1. Final Approval by QA

    1. The QA team is responsible for giving the final approval of test results. Approval signifies that the results are in compliance with product specifications and GMP standards.
    2. Once approved, the test results should be marked as “Approved” in the record and signed off by the QA reviewer.
  2. Action for Out-of-Specification Results

    1. If any test results are out of specification, the batch should be put on hold, and the deviation should be documented and investigated (see SOP for Deviations). Corrective actions should be defined and implemented before proceeding with any further testing or release.

5.4 Storing Test Records

Once test results are approved, the following steps should be taken for storing the records:

  1. Store Records Securely

    1. Store all QC test records, including raw data, reports, and finalized test results, in a secure and organized manner.
    2. Ensure that records are stored in compliance with GMP and that they are easily retrievable for audits or regulatory inspections.
  2. Retain Records for the Required Period

    1. Ensure that QC test records are retained for the period specified by regulatory guidelines (typically 5 years or as required by local regulations).

5.5 Electronic Recordkeeping

If QC test results are documented electronically, the following steps must be followed:

  1. Ensure Compliance with 21 CFR Part 11

    1. Ensure that the electronic recordkeeping system complies with 21 CFR Part 11 requirements, including audit trails, data integrity, and user access controls.
    2. Maintain backup copies of all electronic records in case of system failure or data loss.
  2. Access Control

    1. Ensure that only authorized personnel can enter or modify QC test results in the electronic record system. Maintain user-specific logins and passwords.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • CoA: Certificate of Analysis
  • BPR: Batch Packing Record

7. Documents

  1. Annexure 1: QC Test Results Logbook Template
  2. Annexure 2: QC Test Results Review Checklist
  3. Annexure 3: Out-of-Specification Report Template

8. References

  • Good Manufacturing Practice (GMP) Guidelines
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: QC Test Results Logbook Template

Test Date Batch Number Test Name Test Results Test Method Remarks Signed By
01/03/2025 Batch 001 Assay 99.5% HPLC Within specification John Doe

Annexure 2: QC Test Results Review Checklist

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Test Parameter Review Status Comments
Assay Reviewed Within specification
Dissolution Reviewed Passes all time points

Annexure 3: Out-of-Specification Report Template

Deviation ID Test Parameter Batch Number Test Result Specification Corrective Actions Approval Status
OOS-001 Dissolution Batch 001 Failure at 60 minutes Not less than 80% Re-test at different conditions Approved by QA

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 documenting QC test results QA Head
01/02/2025 2.0 Updated review and approval procedures Revised to include OOS reporting process QA Head
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