related documentation within the facility.

3. Responsibilities

• Initiator (Production/QC/Engineering/QA): Identify and report the deviation or incident.
• Department Head: Provide initial evaluation and classify the deviation.
• QA Officer: Review, investigate, and coordinate deviation closure.
• QA Head: Final approver for deviation and incident closure, including CAPA justification.

4. Accountability

The Head of Quality Assurance is accountable for ensuring timely review, investigation, root cause analysis, and closure of all deviations and incidents reported under this SOP.

5. Procedure

5.1 Definitions

• Deviation: Any departure from an approved instruction, procedure, specification, or expected practice.
• Incident: An unplanned event that may or may not impact product quality or GMP compliance.

5.2 Types of Deviations

• Planned Deviation: A pre-approved temporary change to a documented procedure or standard.
• Unplanned Deviation: An unexpected non-conformance during operations, documentation, or environmental conditions.
• Critical Deviation: A deviation likely to impact product quality or patient safety.
• Major/Minor Deviation: Classified based on potential risk, as per QA guidelines.

5.3 Reporting the Deviation or Incident

1. Any employee who observes a deviation must immediately inform their supervisor and fill the Deviation and Incident Notification Form (Annexure-1).
2. Provide:
   • Description of the event
   • Date/time and location
   • Persons involved
   • Immediate corrective action (if any)
3. Submit the completed form to QA within 24 hours of observation.

5.4 Initial QA Review and Classification

1. QA reviews the notification and classifies the event:
   • Critical
   • Major
   • Minor
   • Planned/Unplanned
2. QA assigns a unique Deviation Number (e.g., DEV/2025/024) and updates the Deviation Register (Annexure-2).

5.5 Investigation and Root Cause Analysis

1. Initiate a formal investigation within 48 hours for critical/major deviations.
2. Use tools such as:
   • 5 Whys
   • Ishikawa (Fishbone) Diagram
   • Brainstorming Sessions
3. Document the findings and supporting evidence in the Investigation Report (Annexure-3).

5.6 CAPA (Corrective and Preventive Action)

1. Propose CAPA based on investigation outcome:
   • Corrective Action – To address the immediate issue
   • Preventive Action – To prevent recurrence
2. Assign responsibility and timelines for implementation.
3. Track implementation in the CAPA Tracker (Annexure-4).

5.7 Review and Approval

1. QA verifies the investigation and effectiveness of CAPA.
2. Approve deviation closure only after all CAPA actions are completed and verified.
3. Close the deviation formally and archive all records securely.

5.8 Planned Deviations

1. Submit a Planned Deviation Request (Annexure-5) to QA before execution of the temporary change.
2. Clearly mention:
   • Justification
   • Duration
   • Impact assessment
   • Temporary controls
3. QA approves the planned deviation prior to implementation and monitors its closure post-expiry.

5.9 Trending and Periodic Review

1. QA shall maintain deviation trends and submit quarterly summaries to management during review meetings.
2. Analyze trends for:
   • Repetition by area or activity
   • Common root causes
   • Recurring personnel errors
3. Initiate training or process improvements based on trends.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practices
• OOS: Out of Specification

7. Documents

1. Deviation and Incident Notification Form (Annexure-1)
2. Deviation Register (Annexure-2)
3. Investigation Report (Annexure-3)
4. CAPA Tracker (Annexure-4)
5. Planned Deviation Request Form (Annexure-5)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.100 – Written Procedures; Deviations
• WHO TRS No. 986 – Annex 2

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation and Incident Notification Form

Date	Initiator	Description	Immediate Action	QA Initials
13/04/2025	Rajesh Kumar	Wrong line sequence during batch setup	Process stopped	SN

Annexure-2: Deviation Register

Deviation No.	Date	Type	Area	Status
DEV/2025/024	13/04/2025	Unplanned	Production	Open

Annexure-3: Investigation Report

Deviation No.	Root Cause	Evidence Reviewed	Conclusion
DEV/2025/024	Operator error	Batch records and CCTV	Retraining required

Annexure-4: CAPA Tracker

CAPA ID	Description	Owner	Target Date	Status
CAPA/2025/011	Retrain operators on batch setup	QA	20/04/2025	In Progress

Annexure-5: Planned Deviation Request Form

Date	Requested By	Deviation Summary	Justification	QA Approval
12/04/2025	Sunita Reddy	Use alternate filter for sampling	Primary filter out of stock	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP	New Implementation	QA Head
14/04/2025	2.0	Planned deviation form added	Audit recommendation	QA Head