plans.

QA Department: Review and approve rework/reprocessing proposals and oversee execution.

QC Department: Perform analytical testing before and after rework/reprocessing.

4. Accountability

The QA Head is accountable for approving rework/reprocessing procedures and ensuring regulatory compliance. The Production Head is responsible for execution as per approved protocol.

5. Procedure

5.1 Definitions

• Rework: Subjecting non-conforming product to one or more processing steps different from original manufacturing process.
• Reprocessing: Repeating one or more steps of the original manufacturing process.

5.2 Identification of Non-Conformance

1. Identify deviations in physical, chemical, or microbiological specifications during IPC or final QC testing.
2. Record findings in the Batch Manufacturing Record (BMR) and notify QA.

5.3 Proposal and Approval

1. Production team shall prepare a “Rework/Reprocessing Proposal Form” (Annexure-1).
2. Include:
   • Batch details
   • Root cause
   • Proposed method
   • Justification
   • Risk assessment
3. QA reviews the proposal with QC and approves if compliant with regulatory guidelines and internal quality risk management practices.

5.4 Execution of Rework/Reprocessing

1. Execute only after QA approval.
2. Follow instructions outlined in the approved plan.
3. Document all activities separately in “Rework/Reprocessing Execution Log” (Annexure-2).
4. Label material appropriately during each stage of reprocessing (e.g., “Under Rework”).

5.5 Testing and Disposition

1. Submit samples to QC for complete analysis after rework/reprocessing.
2. Compare test results with original specifications and document in the COA.
3. Only QA shall approve release or rejection of the batch after reprocessing.
4. Retain full documentation in batch file and deviation records.

5.6 Regulatory and Stability Considerations

1. If reprocessing/rework is included in approved regulatory filing, no further approval is needed.
2. If not included, regulatory affairs shall be consulted before execution.
3. Perform stability studies if reprocessing has potential to impact product shelf life.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• IPC: In-Process Control
• BMR: Batch Manufacturing Record
• COA: Certificate of Analysis

7. Documents

1. Rework/Reprocessing Proposal Form (Annexure-1)
2. Rework/Reprocessing Execution Log (Annexure-2)
3. QC Report Post-Reprocessing (Annexure-3)

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Subpart F & J
• WHO GMP Guidelines – Rework and Reprocessing Section

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Rework/Reprocessing Proposal Form

Batch No.	Product	Issue Observed	Proposed Method	Justification	Approved By
API-202504	API-X	Low Assay	Recrystallization	Restores potency

Annexure-2: Rework/Reprocessing Execution Log

Date	Batch No.	Executed Step	Performed By	Observed Results
13/04/2025	API-202504	Repeat Crystallization		Clear crystals formed

Annexure-3: QC Report Post-Reprocessing

Batch No.	Parameter	Result	Limit	Status
API-202504	Assay	99.2%	98.0–102.0%	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New GMP Process	QA Head
13/04/2025	2.0	Added regulatory filing considerations	Audit Requirement	QA Head