control, quality assurance, and warehouse operations within the sterile injectable manufacturing unit.

3. Responsibilities

• Initiator: Identifies and reports deviation by filling out the deviation form.
• QA Executive: Logs, reviews, investigates, and tracks deviations; ensures CAPA initiation.
• Department Head: Provides investigation support and ensures CAPA implementation.
• QA Manager: Reviews and approves investigation and CAPA; decides on batch disposition.

4. Accountability

Head – Quality Assurance is accountable for effective deviation management, ensuring closure within the stipulated time and compliance with GMP standards.

5. Procedure

5.1 Deviation Identification and Initiation

1. Deviation may be identified during any operation, audit, or quality check.
2. The concerned person must inform the supervisor and QA immediately.
3. Fill out the Deviation Form (Annexure-1) and submit to QA within 24 hours of detection.

5.2 Deviation Logging and Numbering

1. QA assigns a unique deviation number in the Deviation Register (Annexure-2).
2. Number format: DEV/DEPT/XXX/YY (e.g., DEV/MFG/045/25).

5.3 Deviation Classification

1. QA classifies deviations as:
   • Critical: May affect product quality/safety.
   • Major: Significant process/documentation lapses with potential indirect impact.
   • Minor: Low-risk procedural lapses.

5.4 Investigation and Impact Assessment

1. QA, along with the department head, conducts root cause analysis using tools such as 5-Why or Fishbone diagram.
2. Assess product impact, batch status, and regulatory reporting requirement.
3. Document findings in Deviation Investigation Report (Annexure-3).

5.5 Corrective and Preventive Actions (CAPA)

1. Responsible person proposes CAPA using CAPA Form (Annexure-4).
2. QA verifies and tracks CAPA implementation within 30 days.
3. Re-train employees where required and update related SOPs.

5.6 Deviation Closure

1. QA reviews CAPA completion and effectiveness check.
2. Update Deviation Closure Status Log (Annexure-5).
3. Deviation must be closed within 30 working days. If not, justify with reasons and revised timeline.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practices

7. Documents

1. Deviation Form – Annexure-1
2. Deviation Register – Annexure-2
3. Deviation Investigation Report – Annexure-3
4. CAPA Form – Annexure-4
5. Deviation Closure Status Log – Annexure-5

8. References

• WHO TRS 986 Annex 2 – GMP Guidelines
• ICH Q9 – Quality Risk Management
• 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	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Deviation Form

Deviation No.	DEV/MFG/045/25
Date	10/06/2025
Department	Manufacturing
Description	pH meter calibration missed
Initiator	Rajesh Kumar

Annexure-2: Deviation Register

Deviation No.	Date	Department	Status
DEV/MFG/045/25	10/06/2025	Manufacturing	Open

Annexure-3: Deviation Investigation Report

Root Cause	Missed schedule in calendar
Impact	None, instrument not used
Investigator	Sunita Reddy

Annexure-4: CAPA Form

Corrective Action	Re-train staff
Preventive Action	Setup alert system for calibration
Responsible Person	Anita Mehta

Annexure-5: Deviation Closure Status Log

Deviation No.	Closure Date	Verified By	Status
DEV/MFG/045/25	25/06/2025	QA Officer	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP implementation	QA Head
18/06/2025	2.0	Updated with annexures and CAPA workflow	Annual review	QA Head