SOP Guide for Pharma

SOP for Verification of Testing Reports Before Releasing Materials from Quarantine – V 2.0

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SOP for Verification of Testing Reports Before Releasing Materials from Quarantine – V 2.0

Standard Operating Procedure for Verification of Testing Reports Before Releasing Materials from Quarantine

Department Quality Assurance / Quality Control / Warehouse
SOP No. SOP/RM/090/2025
Supersedes SOP/RM/090/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for verifying testing reports before releasing raw materials from quarantine. The purpose is to ensure that all materials meet predefined quality standards and regulatory requirements prior to use in manufacturing.

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, stored in quarantine and pending release for manufacturing or further processing.

3. Responsibilities

4. Accountability

The QA Manager is accountable for verifying testing reports and ensuring compliance with regulatory standards. The QC Manager is responsible for providing accurate and complete testing documentation.

5. Procedure

5.1 Collection and Preparation of Testing Reports

  1. QC Testing Completion:
    • QC personnel complete all required tests as per the approved material specifications.
    • Document test results in the QC Testing Report (Annexure-1) and sign off by the analyst and reviewer.
  2. Compilation of Documentation:
    • Ensure the testing report includes:
      • Material Name and Batch/Lot Number
      • Test Methods and Specifications
      • Test Results (Physical, Chemical, Microbiological)
      • Signatures of the Analyst and Reviewer
      • Certificate of Analysis (CoA) from the supplier (if applicable)
See also  SOP for Documentation of Raw Material Storage Conditions - V 2.0

5.2 QA Verification of Testing Reports

  1. Initial Review:
    • QA reviews the testing report for completeness, accuracy, and adherence to specifications.
    • Verify that all tests required by the material specification sheet have been conducted and results meet acceptance criteria.
  2. Cross-Verification:
    • Compare the testing report with the Certificate of Analysis (CoA) from the supplier, if applicable.
    • Check for consistency between supplier data and internal testing results.
  3. Review of Deviations or Out-of-Specification (OOS) Results:
    • If any deviations or OOS results are found, document them in the Deviation Log (Annexure-2) and initiate an investigation as per SOP for OOS Handling.

5.3 Approval for Material Release

  1. Final Approval:
    • If all results conform to specifications, QA signs the Material Release Authorization Form (Annexure-3).
  2. Updating Records:
    • Record the release decision in the Quarantine Release Log (Annexure-4).
    • Communicate the release decision to the warehouse for updating material status.

5.4 Handling of Non-Conforming Materials

  1. Rejection Process:
    • If materials fail to meet specifications, QA documents the rejection decision in the Material Rejection Form (Annexure-5).
    • Update the Quarantine Rejection Log (Annexure-6) and communicate the rejection decision to the warehouse.
  2. Corrective Actions:
    • Initiate a corrective action process for recurrent non-conformances and document in the Corrective Action Log (Annexure-7).

5.5 Documentation and Record-Keeping

  1. Retention of Testing Reports:
    • Maintain all verified testing reports and related documentation for the duration specified in the document retention policy.
  2. Audit and Compliance Records:
    • QA conducts periodic audits of the verification process to ensure compliance with SOP and regulatory standards.
    • Document audit findings in the Compliance Audit Log (Annexure-8).
See also  SOP for Handling Temperature Deviations in Received Materials - V 2.0

5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All QA and QC personnel must be trained in the procedures for verifying testing reports and material release processes.
    • Document training in the Training Log (Annexure-9).
  2. Compliance Monitoring:
    • QA regularly monitors compliance with this SOP to ensure ongoing adherence to regulatory and quality standards.

6. Abbreviations

7. Documents

  1. QC Testing Report (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Material Release Authorization Form (Annexure-3)
  4. Quarantine Release Log (Annexure-4)
  5. Material Rejection Form (Annexure-5)
  6. Quarantine Rejection Log (Annexure-6)
  7. Corrective Action Log (Annexure-7)
  8. Compliance Audit Log (Annexure-8)
  9. Training Log (Annexure-9)

8. References

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 Testing Report

Date Material Name Batch Number Test Conducted Result Tested By
01/02/2025 API-X API-X-2025-001 Purity Test 99.2% Sunita Sharma
See also  SOP for Designation of Sampling Zones in Quarantine Area - V 2.0

Annexure-2: Deviation Log

Date Material Name Batch Number Description of Deviation Reported By
02/02/2025 API-X API-X-2025-001 Minor discrepancy in CoA data Ajay Singh

Annexure-3: Material Release Authorization Form

Date Material Name Batch Number Approved By Signature
03/02/2025 API-Y API-Y-2025-002 Anjali Mehta

Annexure-4: Quarantine Release Log

Date Material Name Batch Number Release Decision Released By
03/02/2025 API-Y API-Y-2025-002 Released QA Manager

Annexure-5: Material Rejection Form

Date Material Name Batch Number Rejected By Reason for Rejection
04/02/2025 API-Z API-Z-2025-003 Anjali Mehta Failed Microbial Testing

Annexure-6: Quarantine Rejection Log

Date Material Name Batch Number Rejection Decision Rejected By
04/02/2025 API-Z API-Z-2025-003 Rejected QA Manager

Annexure-7: Corrective Action Log

Date Non-Conformance Description Corrective Action Implemented By Verified By (QA)
05/02/2025 Discrepancy in CoA Data Supplier Notified and Corrected CoA Issued Ajay Singh Anjali Mehta

Annexure-8: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
06/02/2025 Testing Report Verification Audit Minor Documentation Errors Found Revised Documentation Procedures Anjali Mehta

Annexure-9: Training Log

Date Training Topic Trainer Attendee Name Signature
07/02/2025 Verification of Testing Reports QA Manager Sunita Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
01/02/2025 2.0 Updated Testing Verification Procedures for Regulatory Compliance Regulatory Compliance QA Head
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