allocated for the audit process and that audit recommendations are acted upon promptly.

4. Accountability

The Manufacturing Manager is accountable for ensuring that internal audits are conducted in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Planning the Internal Audit

1. Determine the scope and objectives of the audit, including areas to be audited (e.g., production processes, equipment, materials, compliance with GMP, etc.).
2. Identify the audit team members, ensuring they have the necessary expertise and are independent of the processes being audited.
3. Create an audit schedule, including the specific dates for the audit and a list of areas to be audited.
4. Inform the relevant departments (e.g., production, maintenance, quality control) about the upcoming audit, providing them with sufficient notice and any requirements (e.g., documentation, access to facilities).
5. Prepare the audit checklist (Annexure-1), which should include all the critical points to be reviewed during the audit, based on GMP regulations and company policies.

5.2. Conducting the Internal Audit

1. During the audit, the audit team will review the following:
   • Compliance with production procedures, including raw material handling, equipment use, and manufacturing processes.
   • Accuracy and completeness of batch records, including deviations and corrective actions taken.
   • Condition and calibration of equipment used during production.
   • Implementation of safety and environmental regulations.
   • Personnel training and qualifications in relation to GMP and production processes.
2. Interview key personnel to understand their roles and responsibilities in relation to GMP compliance and production practices.
3. Document all observations, including non-conformities, deviations, and areas for improvement, in the Audit Findings Log (Annexure-2).
4. If any immediate issues are identified, the audit team should notify the responsible personnel and, if necessary, stop production to prevent any further non-compliance.

5.3. Documenting Audit Findings

1. After the audit, the audit team must compile all findings, including non-compliance issues, process inefficiencies, and areas of improvement, into an Audit Report (Annexure-3).
2. The Audit Report should include:
   • A summary of the audit scope and objectives.
   • A list of areas audited, along with findings and recommendations.
   • A list of any corrective actions taken during the audit (if applicable).
   • Suggestions for improvements in processes, equipment, or documentation.
3. The Audit Report must be reviewed by the Quality Assurance (QA) team, and any issues must be followed up with corrective actions.

5.4. Corrective Actions and Follow-Up

1. After the audit, the production team and other relevant departments must implement corrective actions to address any non-conformities identified during the audit.
2. The QA team will track the implementation of corrective actions and verify that they have been effectively carried out. This may include:
   • Re-training of staff on procedures.
   • Modification of equipment or production processes.
   • Improvement in documentation practices or batch record accuracy.
3. The corrective actions should be documented in the Corrective Action Log (Annexure-4), including the person responsible, due dates, and the status of implementation.
4. Once corrective actions are implemented, the audit team or QA team will verify the actions and close the audit findings.

5.5. Documentation and Record-Keeping

1. Ensure that all audit records, including the Audit Report, Audit Findings Log, and Corrective Action Log, are properly documented and stored in the document management system.
2. All audit records should be accessible for future reference, including internal reviews and external inspections by regulatory authorities.
3. Ensure that audit records are retained for a minimum of 3 years, or as required by regulatory requirements.

5.6. Reporting to Management

1. The final audit report, including a summary of findings and corrective actions, must be presented to the management team for review.
2. Management should review the audit results, discuss any significant issues, and allocate resources for the implementation of corrective actions where necessary.
3. Management should also assess the effectiveness of the internal audit process and suggest improvements to the audit process if needed.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure
• QA: Quality Assurance

7. Documents

1. Audit Checklist (Annexure-1)
2. Audit Findings Log (Annexure-2)
3. Audit Report (Annexure-3)
4. Corrective Action Log (Annexure-4)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Audit Checklist

Audit Area	Checklist Item	Yes/No	Comments
Raw Material Handling	Are raw materials stored properly?	Yes	Stored in designated areas

Annexure-2: Audit Findings Log

Finding ID	Audit Area	Finding Description	Corrective Action	Responsible Person
FIND-001	Raw Material Handling	Improper labeling on materials	Re-labeled all raw materials	Rajesh Patel

Annexure-3: Audit Report

Audit ID	Audit Date	Auditor Name	Findings Summary	Corrective Action Summary
AUD-001	06/02/2025	Rajesh Patel	Minor non-conformances in labeling	Corrective action implemented, materials re-labeled

Annexure-4: Corrective Action Log

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Finding ID	Corrective Action	Implementation Date	Responsible Person	Status
FIND-001	Re-labeled materials	07/02/2025	Rajesh Patel	Completed

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated audit process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures