systems.

2. Scope

This SOP applies to all departments involved in sterile injectable manufacturing including production, quality control, engineering, warehouse, validation, and documentation functions. It encompasses routine, focused, and follow-up audits.

3. Responsibilities

• Audit Coordinator (QA): Plans and schedules audits, assigns auditors, ensures report compilation and closure of audit observations.
• Auditors: Conduct audits objectively and document findings.
• Auditees: Provide access to information, cooperate with auditors, and implement corrective actions.
• Department Heads: Review and respond to audit findings, ensure closure of non-conformities.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that internal audits are conducted as per the approved schedule and that non-conformances are resolved in a timely and effective manner.

5. Procedure

5.1 Preparation of Audit Schedule

1. The Audit Coordinator shall prepare an annual internal audit schedule (Annexure-1) at the beginning of the calendar year based on risk assessment and past audit findings.
2. The schedule shall be reviewed and approved by the Head QA and communicated to all departments.

5.2 Selection and Training of Auditors

1. Auditors shall be selected from QA and trained in auditing principles, GMP guidelines, and applicable regulatory standards.
2. They must be independent of the areas being audited.

5.3 Conducting the Audit

1. Auditors shall:
   • Refer to the checklist (Annexure-2) for each department/process.
   • Review documents, observe activities, and interview personnel.
   • Record all observations, including non-conformities (NC), observations (OBS), and suggestions (SUG).

5.4 Classification of Findings

1. Non-conformities shall be categorized as:
   • Critical: Impacting product quality or patient safety.
   • Major: Deviation from SOPs, GMP, or documentation norms.
   • Minor: Low-risk procedural or documentation lapses.

5.5 Reporting

1. Audit Report (Annexure-3) shall be prepared within 5 working days of the audit and submitted to the auditee department and QA Head.
2. It shall include summary, classification, and suggested corrective actions.

5.6 Corrective and Preventive Actions (CAPA)

1. Auditee departments must submit CAPA plans (Annexure-4) within 10 working days.
2. CAPAs must include root cause analysis, corrective measures, and preventive steps.

5.7 Follow-Up and Closure

1. QA shall verify implementation of CAPAs through:
   • Review of records
   • Follow-up audits if necessary
2. Closure of each audit shall be recorded in the Audit Closure Log (Annexure-5).

5.8 Documentation and Retention

1. All audit-related documents shall be retained for a minimum of 5 years.
2. They must be available for external audits and inspections.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• NC: Non-Conformance
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practice

7. Documents

1. Internal Audit Schedule – Annexure-1
2. Audit Checklist – Annexure-2
3. Audit Report – Annexure-3
4. CAPA Form – Annexure-4
5. Audit Closure Log – Annexure-5

8. References

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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QA Executive	QA Manager	Head QA
Department	Quality Assurance	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Internal Audit Schedule

Department	Scheduled Date	Auditor(s)
Production	15/01/2025	Sunita Reddy
QC	20/01/2025	Rajesh Kumar

Annexure-2: Audit Checklist

Area	Audit Point	Compliant (Y/N)	Remarks
Documentation	Batch records updated in real-time	Y

Annexure-3: Audit Report

Date	Department	Auditor	Findings	Classification
15/01/2025	Production	Sunita Reddy	Missing calibration record	Major

Annexure-4: CAPA Form

Finding	Root Cause	Corrective Action	Preventive Action	Responsible
Missing calibration	Oversight	Recalibrated equipment	Monthly log audit	Rajesh Kumar

Annexure-5: Audit Closure Log

Audit Date	Department	Closure Date	Verified By
15/01/2025	Production	25/01/2025	QA Manager

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Updated checklist and annexures	Periodic Review	QA Head