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