to all stages of sterile injectable manufacturing where deviations from standard operating procedures, batch records, process parameters, equipment settings, or specifications may occur.

3. Responsibilities

• Manufacturing Personnel: Immediately identify and report any deviation to the supervisor and initiate documentation.
• Quality Assurance (QA): Evaluate deviation reports, conduct investigations, determine impact, and approve corrective/preventive actions (CAPA).
• Department Head: Approves deviation reports and ensures timely closure and implementation of CAPA.

4. Accountability

The Head of Quality Assurance is accountable for ensuring all deviations are addressed in a timely and compliant manner and that appropriate root cause analysis and CAPA are conducted and documented.

5. Procedure

5.1 Identification of Deviation

1. A deviation is defined as any departure from approved procedures, standards, or specifications during manufacturing.
2. Deviations may include: process interruptions, equipment failure, mislabeling, environmental excursions, incorrect component use, or yield variations.
3. Personnel must immediately inform the Supervisor/QA and record the incident in the Deviation Log Book (Annexure-1).

5.2 Classification of Deviations

1. Minor Deviation: Non-critical impact, such as documentation error, not affecting product quality or compliance.
2. Major Deviation: Potential impact on product quality, safety, efficacy, or regulatory compliance.
3. Critical Deviation: Direct impact on product release, patient safety, or regulatory violation.

5.3 Deviation Documentation

1. Use the Deviation Report Form (Annexure-2) to record full details, including:
   • Nature of deviation
   • Date and time
   • Equipment/area involved
   • Initial observations
   • Personnel involved
2. Attach any supporting data, including batch records, logs, and instrument readings.

5.4 Investigation and Impact Assessment

1. QA initiates investigation within 24 hours of deviation identification.
2. Evaluate batch impact, including possible effect on:
   • Product quality
   • Process integrity
   • GMP compliance
3. Conduct root cause analysis using appropriate tools (e.g., Fishbone diagram, 5 Whys).

5.5 Corrective and Preventive Action (CAPA)

1. Define immediate corrective action to contain the deviation.
2. Design preventive measures to avoid recurrence.
3. Record CAPA details and implementation responsibility in the Deviation Report Form.
4. QA must review effectiveness of CAPA post-implementation.

5.6 Approval and Closure

1. Deviation Report must be reviewed and signed by QA, Manufacturing Head, and approved by Head QA.
2. All deviations shall be closed within 30 calendar days from date of initiation.
3. Maintain all Deviation Reports in QA archive for at least 5 years.

6. Abbreviations

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

7. Documents

1. Deviation Log Book – Annexure-1
2. Deviation Report Form – Annexure-2
3. CAPA Implementation Checklist – Annexure-3

8. References

• 21 CFR Part 211.192 – Production Record Review
• ICH Q10 – Pharmaceutical Quality System
• EU GMP Volume 4 – Chapter 1 and 8

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 Log Book

Sr. No.	Date	Batch No.	Deviation Type	Initials
001	16/06/2025	IM-3025	Major	SK

Annexure-2: Deviation Report Form

Deviation No.	DEV-056
Batch No.	IV-1005
Date & Time	16/06/2025 – 02:45 PM
Description	Observed filling speed deviation beyond defined range
Impact Assessment	No impact on fill volume or sterility
Root Cause	Improper PID setting
CAPA	Technician retrained; parameter settings reviewed

Annexure-3: CAPA Implementation Checklist

CAPA No.	Action	Responsible	Due Date	Status
CAPA-103	Recalibrate filler	Ajay Deshmukh	20/06/2025	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/04/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Added deviation types, annexures, CAPA checklist	Periodic Review	QA Head