quality, patient safety, or regulatory compliance (e.g., microbial contamination, incorrect formulation, equipment failure).

Major Deviation: A deviation that does not directly impact product quality but may affect process efficiency (e.g., exceeding temperature limits, incomplete documentation).

Minor Deviation: A minor procedural deviation with no significant effect on product quality (e.g., slight delay in record entry, minor errors in labeling).

5.2 Identifying and Documenting Deviations

• Any personnel identifying a deviation must report it to the **Production Supervisor or QA Officer** immediately.
• A **Deviation Report** must be initiated, capturing the following details:
  • Date and time of deviation occurrence.
  • Location and process step affected.
  • Detailed description of the deviation.
  • Immediate corrective actions taken.
  • Name of the person reporting the deviation.
• The deviation report must be submitted to QA within **24 hours** of detection.

5.3 Investigation of Deviations

• QA must initiate a **Root Cause Analysis (RCA)** within **48 hours** of receiving a deviation report.
• Investigation methods include:
  • Review of batch records and process logs.
  • Interviews with personnel involved.
  • Analysis of equipment calibration and environmental monitoring records.
• The investigation findings must be recorded in the **Deviation Investigation Report**.
• Critical deviations must be escalated to senior management.

5.4 Corrective and Preventive Action (CAPA) Process

• Based on the deviation investigation, a **CAPA Plan** must be developed.
• Corrective Actions:
  • Immediate steps to rectify the identified deviation.
  • Product recall or batch rejection if necessary.
  • Training of personnel if human error is identified.
• Preventive Actions:
  • Revising SOPs and work instructions.
  • Enhancing equipment calibration and maintenance schedules.
  • Implementing additional quality control checks.
• The CAPA plan must be reviewed and approved by the QA Manager.

5.5 Implementation and Monitoring of CAPA

• The CAPA Coordinator must track the implementation of corrective and preventive actions.
• A **CAPA Effectiveness Check** must be conducted **one month after implementation**.
• QA must verify that no recurrence of the deviation has been observed.

5.6 Review and Approval of Deviation Reports and CAPA

• QA must review all deviation reports monthly.
• CAPA reports must be reviewed quarterly for effectiveness.
• Deviation records and CAPA reports must be archived for a **minimum of 5 years**.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CAPA – Corrective and Preventive Action
• RCA – Root Cause Analysis
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Deviation Report Template (Annexure-1)
• CAPA Implementation Log (Annexure-2)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on Deviation and CAPA Management
• US FDA Guidance on CAPA Implementation

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 Template

Date	Process Step	Deviation Description	Reported By	QA Review
02/02/2025	Mixing Process	Temperature exceeded by 2°C	John Doe	Reviewed

Annexure-2: CAPA Implementation Log

Date	CAPA Action	Responsible Person	Completion Date	Effectiveness Check
02/02/2025	Temperature alarm system installed	Jane Smith	05/02/2025	Verified

12. Revision History

Revision Date	Revision No.	Details	Reason	Approved By
02/02/2025	2.0	Expanded Procedure	Improved CAPA Documentation	QA Head