SOP Guide for Pharma

BA-BE Studies: SOP for Handling Expired Reference Products – V 2.0

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BA-BE Studies: SOP for Handling Expired Reference Products – V 2.0

Standard Operating Procedure for Handling Expired Reference Products in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/012/2025
Supersedes SOP/BA-BE/012/2022
Page No. Page 1 of 12
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To define the procedure for managing expired reference products procured for Bioequivalence (BE) studies, including identification, segregation, documentation, and proper disposal in compliance with applicable regulatory and Good Manufacturing Practice (GMP) requirements.

2. Scope

This SOP is applicable to all expired reference drug products stored at BA/BE facilities or warehouse locations under the control of Regulatory Affairs, Quality Assurance, or Clinical Operations.

3. Responsibilities

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4. Accountability

The Head of Quality Assurance is accountable for ensuring expired reference products are handled, recorded, and disposed in accordance with SOP, GMP, and audit readiness standards.

5. Procedure

5.1 Monitoring Expiry Status

  1. Maintain an inventory log with batch-wise expiry details for all reference products (Annexure-1).
  2. Perform monthly checks on reference stock and identify:
    • Expired batches
    • Batches expiring within the next 60 days
  3. Flag expired stock in Annexure-2: Expired Product Notification Form.

5.2 Segregation of Expired Reference Products

  1. Move expired stock immediately to a designated “Expired Quarantine Area.”
  2. Apply “EXPIRED – NOT FOR USE” label (red color) on all packs.
  3. Update the Reference Product Receipt Record and mark the batch as ‘expired’.

5.3 Documentation and Review

  1. QA to review expiry information and approve further action.
  2. Retain one sample from each expired batch as per audit traceability policy (if applicable).
  3. Document QA decision in Annexure-3: QA Expired Batch Review Form.
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5.4 Disposal Process

  1. Prepare expired product for destruction under QA supervision.
  2. Ensure disposal via an authorized third-party vendor licensed for pharmaceutical waste disposal.
  3. Create a disposal certificate (Annexure-4) and archive with the reference batch file.

5.5 Regulatory Considerations

  1. Ensure that no expired reference product is used in study dosing or bioanalytical testing.
  2. If expired product was used inadvertently, initiate deviation and impact assessment immediately.

6. Abbreviations

7. Documents

  1. Reference Product Inventory Log – Annexure-1
  2. Expired Product Notification Form – Annexure-2
  3. QA Expired Batch Review Form – Annexure-3
  4. Destruction Certificate – Annexure-4

8. References

See also  BA-BE Studies: SOP for Planning of BA/BE Studies - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Reference Product Inventory Log

Batch No. Product Name Expiry Date Status Location
RLD0021 ABC Tablet 100 mg 30/03/2025 Expired Storage Room A

Annexure-2: Expired Product Notification Form

Date of Identification Batch No. Expiry Date Identified By Remarks
01/04/2025 RLD0021 30/03/2025 Ajay Verma Moved to expired stock

Annexure-3: QA Expired Batch Review Form

Batch No. Reviewed By Date Disposition
RLD0021 Sunita Reddy 02/04/2025 Approved for destruction

Annexure-4: Destruction Certificate

Date Batch No. Quantity Destroyed Vendor Authorized By
05/04/2025 RLD0021 100 tablets BioWaste India Pvt Ltd QA Head

Revision History:

Revision Date Revision No. Details Reason Approved By
10/01/2022 1.0 Initial SOP New Document QA Head
17/04/2025 2.0 Included annexures and quarantine area procedure Audit Feedback QA Head
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