the pharmaceutical production facility.

3. Responsibilities

• Production Chemist: Identifies and reports deviations immediately.
• QA Officer: Logs, investigates, and tracks the deviation resolution process.
• Quality Head: Approves deviation reports and ensures implementation of CAPA.

4. Accountability

Quality Assurance department is accountable for deviation control, documentation accuracy, and implementation of preventive measures to avoid recurrence.

5. Procedure

5.1 Types of Deviations

• Planned Deviation: A pre-approved and intentional departure from SOPs or batch manufacturing procedures for justified reasons.
• Unplanned Deviation: A departure from documented procedures due to unforeseen events or operational errors.

5.2 Detection and Immediate Action

1. Any employee identifying a deviation must inform the shift in-charge or supervisor.
2. The deviation must be logged in the Deviation Intimation Form (Annexure-1) with time, location, and description.
3. Production must isolate affected material and label it as “On Hold”.
4. QA must be informed within 30 minutes of detection.

5.3 Initial Assessment by QA

1. QA Officer reviews the deviation details to categorize it as minor, major, or critical.
2. If safety or product quality is at risk, batch processing must be stopped immediately.
3. For minor deviations, a decision may be taken on disposition based on immediate risk assessment.

5.4 Investigation

1. Assign an investigation team comprising QA, Production, and Engineering (if applicable).
2. Conduct root cause analysis (RCA) using tools like the 5-Why technique or Fishbone diagram.
3. Document all findings in the Deviation Investigation Report (Annexure-2).

5.5 Corrective and Preventive Actions (CAPA)

1. Based on RCA, propose CAPA to address the root cause.
2. Assign responsibilities and timelines for each CAPA.
3. Track CAPA implementation status and update records accordingly.

5.6 Final Approval and Closure

1. QA reviews investigation findings and CAPA effectiveness.
2. Deviation is closed formally in the Deviation Register and linked to the batch record.
3. Major or critical deviations must be reviewed during Quality Management Review (QMR).

6. Abbreviations

• CAPA: Corrective and Preventive Action
• RCA: Root Cause Analysis
• QA: Quality Assurance

7. Documents

1. Deviation Intimation Form – Annexure-1
2. Deviation Investigation Report – Annexure-2
3. Batch Manufacturing Record
4. CAPA Implementation Tracker

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• ICH Q9 – 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: Deviation Intimation Form

Batch No.
Date and Time of Deviation
Location
Description of Deviation
Product Name
Immediate Action Taken
Informed To
Signature of Reporter

Annexure-2: Deviation Investigation Report

Deviation ID
Batch No.
Root Cause Identified
Investigation Summary
Corrective Action
Preventive Action
Responsible Person
Timeline
QA Remarks
Final Approval by QA

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Added CAPA and Annexures	Compliance Update	QA Head