operations within the sterile injectable manufacturing facility that are subject to internal audits, including production, QA, QC, engineering, and warehouse operations.

3. Responsibilities

• Lead Auditor: Plans, conducts, and reports audits; ensures objectivity and compliance with audit scope.
• Audit Team Members: Participate in audit execution and documentation.
• Auditees: Provide required documentation, access, and clarifications during audits.
• QA Head: Reviews audit findings and ensures implementation of corrective and preventive actions (CAPA).

4. Accountability

The Head – Quality Assurance is accountable for ensuring that internal audits are conducted periodically and that all observations are addressed through timely CAPA implementation.

5. Procedure

5.1 Audit Planning

1. Prepare an Annual Internal Audit Calendar (Annexure-1).
2. Define audit scope, criteria, objectives, and schedule.
3. Assign lead auditor and audit team ensuring independence from auditee departments.

5.2 Audit Execution

1. Conduct opening meeting to brief the audit plan to department heads.
2. Perform physical inspection, document review, and personnel interviews.
3. Record all observations in Audit Observation Sheet (Annexure-2).
4. Classify findings as critical, major, or minor based on potential risk to product quality.

5.3 Audit Reporting

1. Prepare an Audit Summary Report (Annexure-3) within 5 working days of audit completion.
2. Send report to relevant stakeholders for review and CAPA initiation.

5.4 Corrective and Preventive Actions (CAPA)

1. Departments submit CAPA plans within 10 working days using CAPA Form (Annexure-4).
2. QA verifies adequacy and implementation of CAPA during follow-up audits.

5.5 Audit Closure

1. Once all CAPAs are verified and closed, update the Audit Closure Status Log (Annexure-5).
2. Conduct a closing meeting and document audit closure in the audit report.

6. Abbreviations

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

7. Documents

1. Annual Audit Calendar – Annexure-1
2. Audit Observation Sheet – Annexure-2
3. Audit Summary Report – Annexure-3
4. CAPA Form – Annexure-4
5. Audit Closure Status Log – Annexure-5

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – GMP Requirements
• WHO TRS 986 Annex 2 – GMP for Sterile Products

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: Annual Audit Calendar

Department	Scheduled Audit Date	Lead Auditor
Production	10/01/2025	Sunita Reddy
Warehouse	15/03/2025	Rajesh Kumar

Annexure-2: Audit Observation Sheet

Observation No.	Description	Category	Auditor
OBS-01	Incomplete BMR entries	Major	Sunita Reddy

Annexure-3: Audit Summary Report

Audit Date	12/06/2025
Audited Department	Filling
No. of Observations	3
Report Prepared By	Rajesh Kumar

Annexure-4: CAPA Form

Observation No.	Corrective Action	Preventive Action	Responsible
OBS-01	Train operators on documentation	Introduce BMR checklist	Anita Mehta

Annexure-5: Audit Closure Status Log

Audit ID	Closure Date	Verified By	Status
AUD-2025-01	25/06/2025	QA Officer	Closed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/02/2022	1.0	Initial version	New SOP implementation	QA Head
18/06/2025	2.0	Updated CAPA workflow and annexures	Annual review	QA Head