execution, documentation, and follow-up of internal audits conducted in the gel manufacturing unit at the pharmaceutical plant.

3. Responsibilities

• Quality Assurance Manager: Plans and approves the audit calendar and ensures timely execution.
• Internal Auditor: Conducts audits as per checklist and documents observations.
• Department Heads: Facilitate auditor access and ensure CAPA implementation for audit findings.

4. Accountability

Quality Assurance Department is accountable for the planning, execution, and follow-up of internal audits to verify compliance and continuous process improvement in Gel Manufacturing.

5. Procedure

5.1 Audit Planning

1. QA Manager prepares an Annual Audit Schedule and shares it with all departments by the first week of January.
2. Audits must be conducted at least once per year per department, or more frequently based on risk assessment.

5.2 Pre-Audit Preparation

1. Internal auditor is nominated and provided with:
   • Department-specific audit checklist (Annexure-1)
   • Previous audit reports
   • Relevant SOPs and CAPA records
2. Auditor schedules a mutually agreed date and time with the department head.

5.3 Conducting the Audit

1. Auditor uses the checklist to review documentation, interview personnel, and inspect operations.
2. Observations are classified as:
   • Critical: Impacting product quality or patient safety
   • Major: Affecting GMP compliance
   • Minor: Procedural or documentation lapses
3. All findings are noted in the Internal Audit Observation Form (Annexure-2).

5.4 Audit Reporting

1. Within 3 working days post-audit, a detailed audit report is submitted to QA and the auditee department.
2. Report includes:
   • Audit scope and objective
   • Audit checklist responses
   • Observations and their classification
   • Recommended Corrective and Preventive Actions (CAPA)

5.5 CAPA and Follow-up

1. Auditee department must respond with proposed CAPA within 7 working days.
2. QA reviews and approves CAPA and monitors implementation using the CAPA Tracker.
3. Effectiveness check of CAPA is done within 30 days of closure.

6. Abbreviations

• CAPA: Corrective and Preventive Action
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Annual Audit Schedule – Annexure-1
2. Internal Audit Observation Form – Annexure-2
3. Internal Audit Report
4. CAPA Tracker

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO GMP Guidelines for Internal Audits

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Annual Audit Schedule Format

Department	Audit Month	Planned Date	Auditor Name	Remarks
Gel Manufacturing

Annexure-2: Internal Audit Observation Form

Observation ID
Department	Gel Manufacturing
Date of Audit
Auditor Name
Observation Details
Classification (Critical/Major/Minor)
Proposed CAPA
Target Completion Date
QA Comments

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Updated checklist and annexure format	Annual Review	QA Head