control, engineering, utilities, and support functions.

3. Responsibilities

• QA Department: Prepare audit schedules, assign auditors, conduct audits, document findings, and ensure CAPA closure.
• Auditors: Conduct unbiased evaluations and document observations clearly.
• Auditees (Departments): Facilitate audit process and provide required documents and responses to observations.
• QA Head: Review audit reports and monitor CAPA effectiveness.

4. Accountability

The QA Head is accountable for the successful execution of internal audits and ensuring closure of all observations through timely and effective corrective and preventive actions.

5. Procedure

5.1 Internal Audit Planning

1. QA shall prepare an Annual Internal Audit Schedule (Annexure-1) at the beginning of each calendar year.
2. Frequency of audits:
   • GMP areas – At least once every 6 months
   • Support departments – Once annually
   • Trigger-based audits – As needed following complaints, deviations, or inspections

5.2 Auditor Selection and Training

1. Internal auditors shall be qualified personnel trained in auditing techniques and GMP requirements.
2. Auditors must be independent of the area being audited to ensure objectivity.
3. Training records of auditors shall be maintained by QA.

5.3 Audit Preparation

1. QA shall issue an Internal Audit Intimation (Annexure-2) to the auditee department at least 3 days in advance.
2. Audit Checklist (Annexure-3) shall be prepared based on:
   • Previous audit observations
   • Applicable SOPs, guidelines, and regulatory requirements
   • Any specific focus areas

5.4 Conducting the Audit

1. The audit shall include:
   • Opening meeting with the auditee
   • Facility walkthrough and interviews
   • Review of documents, records, logs, and equipment
2. All observations shall be documented clearly as:
   • Critical: Direct impact on product quality/safety or regulatory non-compliance
   • Major: Potential to affect product quality or documentation integrity
   • Minor: Improvement areas not immediately affecting quality
3. Close the audit with an exit meeting and initial discussion on observations.

5.5 Audit Report Preparation

1. Complete the Internal Audit Report (Annexure-4) within 5 working days of audit completion.
2. Include:
   • Audit date and scope
   • Auditors and auditees involved
   • Observations categorized by severity
   • Photos or evidence if applicable
3. Distribute the report to department heads and management.

5.6 Corrective and Preventive Action (CAPA)

1. Auditee departments shall submit CAPA responses within 10 working days using the CAPA Response Form (Annexure-5).
2. QA shall review the adequacy of CAPA and request clarification if required.
3. QA shall verify effectiveness of actions implemented and document closure in the Audit CAPA Tracker (Annexure-6).

5.7 Re-Audit and Follow-up

1. QA may schedule a re-audit in case of critical observations or ineffective CAPA implementation.
2. Follow-up audits shall be documented using a Follow-Up Audit Form (Annexure-7).

5.8 Audit Summary and Trending

1. QA shall maintain a Master Audit Summary (Annexure-8) capturing:
   • Total audits conducted
   • Observation types and recurring issues
   • CAPA timelines and closures
2. Summarized trends and performance metrics shall be discussed in quarterly Quality Management Review (QMR) meetings.

6. Abbreviations

• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• GMP: Good Manufacturing Practices
• QMR: Quality Management Review

7. Documents

1. Annual Audit Schedule (Annexure-1)
2. Audit Intimation Form (Annexure-2)
3. Audit Checklist (Annexure-3)
4. Internal Audit Report (Annexure-4)
5. CAPA Response Form (Annexure-5)
6. Audit CAPA Tracker (Annexure-6)
7. Follow-Up Audit Form (Annexure-7)
8. Master Audit Summary Sheet (Annexure-8)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.180 – Recordkeeping Requirements
• WHO GMP – Annex 3: Quality Management System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Annual Internal Audit Schedule

Department	Audit Frequency	Planned Date	Status
Production	6 Monthly	01/03/2025	Completed

Annexure-2: Internal Audit Intimation Form

Date	Department	Audit Scope	Auditor
28/02/2025	QC	Data Integrity and Instrument Logs	Rajesh Kumar

Annexure-3: Audit Checklist

Audit Area	Requirement	Compliant (Y/N)	Remarks
Documentation	SOPs in place and current	Y

Annexure-4: Internal Audit Report

Observation No.	Category	Description	Department
01	Major	Incomplete logbook entries	Production

Annexure-5: CAPA Response Form

Observation No.	Root Cause	CAPA Proposed	Target Date
01	Staff unaware of SOP changes	Retraining	10/03/2025

Annexure-6: Audit CAPA Tracker

CAPA ID	Status	Verified By	Closure Date
CAPA/2025/008	Closed	QA	15/03/2025

Annexure-7: Follow-Up Audit Form

Original Audit Date	Re-Audit Date	Findings Closed	Remarks
01/03/2025	10/03/2025	Yes	Effective CAPA

Annexure-8: Master Audit Summary Sheet

Audit No.	Area Audited	Observations	CAPA Status
INT/2025/03	Warehouse	2 Minor	Closed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	Implementation	QA Head
14/04/2025	2.0	Updated audit classification and annexures	Compliance Improvement	QA Head