Procedure for Handling Rejected Packed Units
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/100 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic process for handling rejected packed units in ointment packaging. This ensures product quality, compliance with Good Manufacturing Practices (GMP), and proper documentation of non-conforming products.
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments responsible for identifying, segregating, investigating, and disposing of rejected packed units.
3. Responsibilities
- Packaging Operator: Identifies and segregates rejected packed units.
- Packaging Supervisor: Records and reports rejected units for further investigation.
- Quality Assurance (QA) Officer: Evaluates rejection reasons and recommends corrective actions.
- QA Manager: Approves final disposition of rejected packed units.
4. Accountability
The QA and Packaging Managers are accountable for ensuring that rejected packed units are properly handled, documented, and disposed of per regulatory requirements.
5. Procedure
5.1 Identification of Rejected Packed Units
- Conduct routine inspections to identify defective or non-conforming packed units.
- Common rejection reasons include:
- Incorrect or missing labels
- Damaged or leaking ointment tubes
- Misprinted batch numbers or expiry dates
- Improper sealing or tamper evidence issues
- Packaging material defects (e.g., torn cartons, misaligned inserts)
5.2 Segregation and Quarantine
- Place rejected packed
units in a designated rejection area.
Clearly label rejected units with “REJECTED – DO NOT USE” tags.
Maintain a rejection log for traceability.
5.3 Investigation and Root Cause Analysis
- QA must analyze rejection trends to determine potential root causes.
- Use Corrective and Preventive Action (CAPA) to address recurring issues.
- Perform re-evaluation if required and document findings.
5.4 Disposition of Rejected Units
- Based on QA evaluation, rejected units may be:
- Reprocessed (if feasible and within GMP limits)
- Reworked (e.g., re-labeling, repackaging)
- Destroyed (if unfit for use and beyond salvage)
- QA must approve and document the final disposition method.
5.5 Documentation and Record Keeping
- Record all rejected packed units in the Rejection Log.
- Maintain documentation for regulatory audits and traceability.
- Ensure final approval and closure of the rejection case by QA.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CAPA – Corrective and Preventive Action
7. Documents
- Rejected Packed Units Log (Annexure-1)
- Final Disposition Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q10 – Pharmaceutical Quality System
- USP <41> – Weights and Balances
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Rejected Packed Units Log
| Date | Batch Number | Rejection Reason | Quantity Rejected | Recorded By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Leaking Tube | 10 | Packaging Supervisor | Segregated |
| 01/02/2025 | OINT-102 | Incorrect Expiry Date | 5 | QA Officer | To be reworked |
Annexure-2: Final Disposition Report
| Date | Batch Number | Rejection Category | Disposition Method | Final Approval |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Packaging Defect | Destroyed | QA Manager |
| 02/02/2025 | OINT-102 | Labeling Error | Reworked | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |