exhibit deviations, out-of-specification (OOS) results, visual defects, microbial contamination, or other quality failures identified during any phase of manufacturing at the gel production facility.

3. Responsibilities

• Production Department: Reporting of failures, initial documentation, and support in investigation.
• Quality Assurance (QA): Leading investigations, conducting root cause analysis, CAPA implementation, and closure.
• Quality Control (QC): Analytical testing, data review, and support in investigation.
• Engineering Department: Equipment-related assessment and technical support.

4. Accountability

Head – Quality Assurance shall be accountable for ensuring that all gel batch failures are properly investigated, documented, and closed with appropriate CAPA.

5. Procedure

5.1 Detection and Reporting

1. Any production personnel identifying a potential failure (e.g., non-conforming appearance, consistency, pH, viscosity) shall immediately report to the production supervisor and QA.
2. The concerned gel batch is labeled as “Under Investigation” and moved to quarantine storage.
3. QA logs the incident in the Batch Failure Register (Annexure-1) and initiates an Investigation Report (Annexure-2).

5.2 Investigation Steps

1. QA forms an Investigation Team consisting of representatives from Production, QA, QC, and Engineering.
2. The team gathers the following data:
   • Batch Manufacturing Record (BMR)
   • Equipment cleaning logs
   • Environmental monitoring reports
   • Raw material COAs
   • In-process and final QC test results
3. QA conducts interviews with operators, supervisors, and any personnel involved in the batch processing.
4. Cross-checking of batch data with prior batches to identify recurrence patterns.

5.3 Root Cause Analysis (RCA)

1. Use root cause tools like:
   • 5 Whys Analysis
   • Ishikawa (Fishbone) Diagram
   • Failure Mode and Effect Analysis (FMEA)
2. All potential causes are evaluated to identify the most probable root cause(s).

5.4 Corrective and Preventive Actions (CAPA)

1. Corrective actions are implemented to eliminate the immediate cause of failure.
2. Preventive actions are proposed to prevent recurrence, which may include:
   • Process re-training
   • Procedure revisions
   • Equipment modification
   • Supplier qualification/review
3. CAPA effectiveness is reviewed within 30 days post-implementation.

5.5 Disposition of the Batch

1. Based on investigation outcome and QA decision, batch may be:
   • Rejected
   • Reprocessed (subject to regulatory approval)
   • Reworked
   • Released (if justified)

5.6 Documentation

1. All investigation data is compiled in the Batch Failure Investigation Report (Annexure-2).
2. QA Head signs off the investigation report and updates the Investigation Summary Log (Annexure-3).

6. Abbreviations

• OOS: Out-of-Specification
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• QC: Quality Control
• RCA: Root Cause Analysis

7. Documents

1. Batch Failure Register – Annexure-1
2. Batch Failure Investigation Report – Annexure-2
3. Investigation Summary Log – Annexure-3

8. References

• ICH Q10: Pharmaceutical Quality System
• 21 CFR Part 211 – Subpart J: Records and Reports
• WHO Technical Report Series 986 – Quality Risk Management

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: Batch Failure Register

Entry No.	Date	Batch No.	Product Name	Failure Type	Reported By	QA Reference

Annexure-2: Batch Failure Investigation Report

Report No.
Batch No.
Product
Failure Description
Date Identified
Root Cause Identified
Corrective Actions
Preventive Actions
Disposition Decision
Investigation Closed Date
QA Reviewer

Annexure-3: Investigation Summary Log

Sr. No.	Batch No.	Failure Type	Date Opened	Date Closed	Disposition	QA Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Inclusion of annexures and RCA tools	Periodic Review	QA Head