the implementation of corrective actions and ensuring compliance with audit findings within their respective departments.

Regulatory Affairs: Responsible for ensuring that audit processes comply with external regulatory requirements and that any changes resulting from audits are communicated to regulatory bodies if necessary.

4. Accountability

The QA Manager is accountable for planning, conducting, and managing internal audits. The Production Manager is responsible for ensuring the implementation of corrective actions resulting from audit findings. Department Heads must ensure compliance with audit findings within their departments.

5. Procedure

5.1 Planning the Internal Audit

1. The QA Manager is responsible for planning the internal audit schedule. Audits should be conducted at least once every quarter or as required by regulatory guidelines.
2. The QA team will develop an audit checklist based on the relevant SOPs, production records, quality control logs, and regulatory requirements. The checklist will cover areas such as:
   • Production processes
   • Equipment maintenance and calibration
   • Raw material handling and storage
   • Employee training and qualifications
   • Documentation and record-keeping
   • Compliance with GMP guidelines
3. The audit schedule and checklist will be communicated to the relevant departments in advance to ensure they are prepared for the audit.

5.2 Conducting the Audit

1. The QA team will conduct the audit by reviewing documentation, inspecting production areas, and interviewing personnel involved in the manufacturing process.
2. During the audit, the team will:
   • Verify that production processes follow approved SOPs and specifications.
   • Ensure that all records are complete, accurate, and compliant with internal and regulatory standards.
   • Inspect equipment for cleanliness, calibration, and proper functioning.
   • Assess employee training records to ensure staff is qualified to perform their tasks.
   • Identify any discrepancies, non-compliance issues, or areas for improvement.
3. Findings will be documented in the Internal Audit Report (Annexure-1) with a description of the issue, its impact, and the recommended corrective actions.

5.3 Reporting the Findings

1. After the audit, the QA team will compile the audit findings into a report. The report should include:
   • Summary of audit findings
   • Non-compliance issues and deviations from GMP or internal procedures
   • Recommended corrective actions and preventive actions
   • Deadline for addressing the issues
2. The Internal Audit Report will be shared with the Production Manager, Department Heads, and relevant stakeholders for review and action.
3. If major deviations or non-compliance issues are identified, the QA team may request an immediate meeting with the management team to discuss the findings and plan corrective actions.

5.4 Implementing Corrective and Preventive Actions (CAPA)

1. Following the audit, the responsible departments must implement corrective actions to address any identified non-compliance issues or deviations.
2. The CAPA process should include:
   • Identifying the root cause of the issue
   • Implementing corrective actions to fix the immediate issue
   • Implementing preventive actions to prevent recurrence of the issue
   • Assigning responsibility for implementing and monitoring the actions
3. The QA team will review the proposed corrective and preventive actions to ensure they are adequate and effective.
4. Once the corrective actions are implemented, the QA team will verify their effectiveness through follow-up audits or inspections.

5.5 Monitoring and Follow-up

1. The QA team will monitor the implementation of corrective actions and ensure that they are completed within the agreed timeline.
2. Follow-up audits will be conducted to assess the effectiveness of corrective actions. If necessary, further actions will be taken to ensure that the issue has been fully resolved.
3. All audit-related documentation, including the Internal Audit Report, CAPA log, and follow-up audit reports, will be maintained for future reference and regulatory inspections.

5.6 Documentation and Record-Keeping

1. All audit reports, CAPA logs, and related documentation will be stored and maintained in compliance with GMP guidelines for record-keeping.
2. Documents should be retained for at least two years or as required by regulatory guidelines.
3. Audit records must be organized and readily available for review during internal or external audits.

6. Abbreviations

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

7. Documents

1. Annexure-1: Internal Audit Report
2. Annexure-2: CAPA Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Internal Quality Audits

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Internal Audit Report

Audit Area	Findings	Corrective Action	Responsible Person	Timeline
Production Process	Deviation in temperature control	Calibrate temperature controllers	Production Manager	27/01/2026

Annexure-2: CAPA Log

Corrective Action Description	Preventive Action Description	Implementation Date	Responsible Person
Recalibrate temperature control system	Schedule monthly calibration	27/01/2026	Maintenance Supervisor

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head