Elixir Department: SOP for Deviation Management – V 2.0

Standard Operating Procedure for Deviation Management in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/243/2025
Supersedes	SOP/ELX/243/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the process for identification, documentation, investigation, evaluation, and closure of deviations occurring during the manufacturing, testing, storage, or handling of elixir products in compliance with cGMP.

2. Scope

This SOP is applicable to all planned and unplanned deviations observed in the Elixir Department across production, quality control, warehouse, and engineering operations.

3. Responsibilities

All Department Personnel:
- Report any deviation observed during routine operations.
Department Head:
- Ensure timely documentation and preliminary impact assessment.
QA Officer:
- Initiate deviation number, coordinate investigation, and ensure timely closure.

4. Accountability

The QA Head is accountable for ensuring compliance with this SOP and regulatory expectations related to deviation investigation and control.

5. Procedure

5.1 Types of Deviations

Planned Deviation: A deviation pre-approved by QA for a temporary and controlled change.
Unplanned Deviation: Any unexpected incident or non-compliance with approved procedures or

parameters.

5.2 Identification and Documentation

Any deviation observed must be reported immediately to the department supervisor and QA.
QA shall issue a unique deviation number and deviation form (Annexure-1).
The concerned department must fill in:
- Date and time of deviation
- Brief description
- Batch/product details (if applicable)
- Initial impact assessment

5.3 Investigation and Impact Analysis

QA along with department head shall initiate an investigation.
Determine root cause using tools like:
- Fishbone diagram
- 5 Whys technique
Assess potential impact on:
- Product quality
- Patient safety
- Regulatory compliance

5.4 Corrective and Preventive Action (CAPA)

Propose suitable CAPA based on root cause analysis.
Assign responsible persons and timelines for CAPA execution.
QA shall verify CAPA implementation and effectiveness.

5.5 Deviation Closure

Once investigation and CAPA are complete, QA shall:
- Review deviation file
- Approve closure with remarks
Deviation shall be closed within 30 working days from initiation unless extended with justification.

5.6 Trending and Review

QA shall maintain a Deviation Register (Annexure-2) and trend deviations monthly.
Include deviation trends in Product Quality Review (PQR).

6. Abbreviations

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

7. Documents

Deviation Report Form (Annexure-1)
Deviation Register (Annexure-2)
Root Cause Analysis Record

8. References

21 CFR Part 211.100 – Written Procedures; Deviations
ICH Q10 – Pharmaceutical Quality System
WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products

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 Report Form

Deviation No.	Date	Department	Description	Batch No. (if any)	Initial Impact	Raised By
DEV-ELX-025	11/04/2025	Production	Mixing time exceeded by 10 minutes	ELX-0425-058	Potential impact on homogeneity	Rajesh Kumar

Annexure-2: Deviation Register

Deviation No.	Date	Department	Status	CAPA Implemented	Closed By
DEV-ELX-025	11/04/2025	Production	Closed	Yes	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP Creation	QA Head
11/04/2025	2.0	Integrated CAPA timeline and root cause tools	Compliance Enhancement	QA Head