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
- Warehouse Personnel: Monitor expiry dates and report expired stock.
- Quality Assurance (QA): Verifies expiration, authorizes segregation and disposal.
- Regulatory Affairs: Confirms regulatory requirements related to retention and archiving.
- Clinical Team: Ensures expired products are not used in ongoing or future studies.
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
- Maintain an inventory log with batch-wise expiry details for all reference products (Annexure-1).
- Perform monthly checks on reference stock and identify:
- Expired batches
- Batches expiring within the next 60 days
- Flag expired stock in Annexure-2: Expired Product Notification Form.
5.2 Segregation of Expired Reference Products
- Move expired stock immediately to a designated “Expired Quarantine Area.”
- Apply “EXPIRED – NOT FOR USE” label (red color) on all packs.
- Update the Reference Product Receipt Record and mark the batch as ‘expired’.
5.3 Documentation and Review
- QA to review expiry information and approve further action.
- Retain one sample from each expired batch as per audit traceability policy (if applicable).
- Document QA decision in Annexure-3: QA Expired Batch Review Form.
5.4 Disposal Process
- Prepare expired product for destruction under QA supervision.
- Ensure disposal via an authorized third-party vendor licensed for pharmaceutical waste disposal.
- Create a disposal certificate (Annexure-4) and archive with the reference batch file.
5.5 Regulatory Considerations
- Ensure that no expired reference product is used in study dosing or bioanalytical testing.
- If expired product was used inadvertently, initiate deviation and impact assessment immediately.
6. Abbreviations
- BE: Bioequivalence
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- SOP: Standard Operating Procedure
7. Documents
- Reference Product Inventory Log – Annexure-1
- Expired Product Notification Form – Annexure-2
- QA Expired Batch Review Form – Annexure-3
- Destruction Certificate – Annexure-4
8. References
- Schedule Y of Drugs and Cosmetics Act, India
- WHO Good Clinical Practice Guidelines
- USFDA Bioequivalence Study Inspection Compliance Program
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 |