storage areas during operations. These may include environmental excursions, power interruptions, equipment breakdowns, procedural deviations, and utility failures.

3. Responsibilities

• Initiator (Operator/Supervisor): Immediately identifies and documents the unplanned event.
• Department Head: Evaluates preliminary impact and notifies QA.
• QA Officer: Performs assessment, categorization, and initiates documentation and investigation.
• QA Manager: Approves final disposition, ensures corrective/preventive actions are implemented.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that all unplanned events are properly managed, investigated, and closed as per defined timelines and in accordance with GMP guidelines.

5. Procedure

5.1 Identification and Initial Action

1. Any GMP personnel observing an unplanned event must immediately:
   • Stop the process (if necessary)
   • Secure product and environment
   • Inform the area supervisor
2. The supervisor shall record initial details in the Unplanned Event Notification Form (Annexure-1) and notify QA.

5.2 Classification of Unplanned Event

1. QA shall classify the unplanned event based on impact:
   • Minor: No impact on product quality or GMP compliance
   • Major: Potential or confirmed impact on quality/process
   • Critical: Definite impact on product, requires immediate action or regulatory notification
2. Classification shall be recorded in the Unplanned Event Register (Annexure-2).

5.3 Documentation and Evaluation

1. The QA Officer shall:
   • Log the event in the tracking system
   • Assign a unique reference number (e.g., UE-API-2025-007)
   • Initiate the Unplanned Event Investigation Form (Annexure-3)
2. Department Head and QA shall jointly perform impact assessment and risk evaluation using the Risk Assessment Template (Annexure-4).

5.4 Root Cause Analysis

1. Use tools such as:
   • 5 Whys
   • Ishikawa (Fishbone) Diagram
2. Document RCA in Section C of the Investigation Form and attach supporting evidence.

5.5 Corrective and Preventive Actions (CAPA)

1. Define:
   • Corrective Actions: To address the current issue
   • Preventive Actions: To prevent recurrence
2. QA shall approve CAPA plan and assign target dates and responsible persons.
3. Track progress in the Unplanned Event CAPA Log (Annexure-5).

5.6 QA Review and Closure

1. QA Manager shall:
   • Verify CAPA implementation
   • Ensure effectiveness checks
   • Review supporting documentation
2. Closure shall be documented in the final section of the Investigation Form and approved by QA.

5.7 Trending and Reporting

1. QA shall trend unplanned events monthly using the Event Trending Sheet (Annexure-6).
2. Trends must be reviewed during:
   • Quarterly Quality Review Meetings
   • Annual Product Quality Review (PQR)

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• RCA: Root Cause Analysis
• PQR: Product Quality Review

7. Documents

1. Unplanned Event Notification Form – Annexure-1
2. Unplanned Event Register – Annexure-2
3. Unplanned Event Investigation Form – Annexure-3
4. Risk Assessment Template – Annexure-4
5. Unplanned Event CAPA Log – Annexure-5
6. Event Trending Sheet – Annexure-6

8. References

• ICH Q10 – Pharmaceutical Quality System
• EU GMP Chapter 1 – Quality System
• 21 CFR 211.100 – Written Procedures
• WHO Technical Report Series No. 981 – GMP for APIs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Unplanned Event Notification Form

Date	Time	Area	Description	Initiator
12/04/2025	10:15 AM	Granulation Room	Power interruption during drying	Rajesh Kumar

Annexure-2: Unplanned Event Register

Event ID	Date	Classification	Status	Closed On
UE-API-2025-007	12/04/2025	Major	Closed	14/04/2025

Annexure-3: Unplanned Event Investigation Form

Event ID	Description	Initial Assessment	RCA Summary	QA Review
UE-API-2025-007	Equipment stopped during granulation	Batch on hold	Loose wire in panel	Impact nullified

Annexure-4: Risk Assessment Template

Parameter	Severity	Probability	Detectability	Risk Score
Batch impact	Medium	Low	High	6

Annexure-5: Unplanned Event CAPA Log

CAPA ID	Action	Owner	Due Date	Status
CAPA/2025/018	Replace panel wire	Engineering	13/04/2025	Completed

Annexure-6: Event Trending Sheet

Month	Minor	Major	Critical	Total
March 2025	4	2	0	6

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
14/04/2025	2.0	Added annexures and classification tiers	Internal Audit Recommendation	QA Head