Investigates rejection cause, approves segregation, and monitors corrective action.

4. Accountability

The Head – Manufacturing is accountable for ensuring adherence to this SOP and taking necessary actions to prevent recurrence of rejections.

5. Procedure

5.1 Identification and Segregation

1. Immediately identify and report non-conforming gel material such as discolored gel, presence of foreign matter, abnormal odor, incorrect pH, etc.
2. Physically segregate the affected material and label with “Rejected – Under Investigation”.
3. Record batch details, quantity, rejection type, and location of segregation in the In-Process Rejection Log – Annexure-1.

5.2 Investigation and Documentation

1. Production Supervisor initiates an internal deviation report or rejection form.
2. QA investigates root cause, evaluates impact on product quality, and determines disposition.
3. Document all findings in the Rejection Investigation Report – Annexure-2.

5.3 Disposition of Rejected Material

1. If the rejection is due to correctable issues (e.g., pH adjustment), reprocessing may be considered upon QA approval.
2. If the rejection is due to contamination or irreversible degradation, dispose of the material as per SOP on Waste Disposal.
3. QA must authorize and document the destruction of rejected material using Destruction Record – Annexure-3.

5.4 Corrective and Preventive Action

1. Root cause trends to be analyzed quarterly by QA for recurring rejection reasons.
2. CAPA to be initiated where applicable and tracked through the QA CAPA system.

5.5 Line Clearance and Process Continuation

1. After segregation and corrective measures, the manufacturing area must be cleared by QA before resumption.
2. Ensure all records are updated and traceable for audit readiness.

6. Abbreviations

• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• GMP: Good Manufacturing Practices

7. Documents

1. In-Process Rejection Log – Annexure-1
2. Rejection Investigation Report – Annexure-2
3. Destruction Record – Annexure-3
4. Batch Manufacturing Record

8. References

• WHO Technical Report Series 986 – Annex 2: GMP for Pharmaceutical Products
• 21 CFR Part 211 – Subpart F: Production and Process Controls

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: In-Process Rejection Log

Date	Batch No.	Stage	Type of Rejection	Qty Rejected	Segregation Status	Operator Initial

Annexure-2: Rejection Investigation Report

Batch No.
Nature of Rejection
Initial Observation Date
Root Cause
Impact Assessment
Disposition Decision
QA Remarks

Annexure-3: Destruction Record

Date	Batch No.	Material	Qty Destroyed	Method	Approved By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
12/05/2022	1.0	Initial Issue	New SOP	QA Head
09/06/2025	2.0	Format aligned with Annexures and investigation process refined	Annual Review	QA Head