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					Auditing Guide

Appendix D – Audit Report

21/11/02

Company, Date:

Audit Report

Audit Report
Company Location Adress Country Subject of Audit

Audit Date Auditor (lead) Co-Auditor(s) Participants Signature of Auditor(s)

Lead Auditor Attachments

Co-Auditor

21/11/02

Company, Date:

Audit Report

Management Summary
Purpose of audit

Conclusions

Acknowledgements

21/11/02

Audit Report
Classification Target Date

Company, Date:

No.
Reference

Auditors Observations

Response of Auditee

Responsibility

21/11/02

page 4 of 7

Audit Report
Classification Target Date

Company, Date:

No.
Reference

Auditors Observations

Response of Auditee

Responsibility

21/11/02

Page 5 of 7

Audit Report
Classification Target Date

Company, Date:

No.
Reference

Auditors Observations

Response of Auditee

Responsibility

21/11/02

Page 6 of 7

Audit Report

Company, Date:

Key for Classification of observations

Urgency

Classification rating

R

The condition will seriously affect the quality of products, regulatory compliance. The condition violates essential GMP-rules and basic quality assurance practices. Immediate action should be taken. The condition may affect the quality of the product, regulatory compliance. The condition violates GMP-rules and quality assurance practices. Action is recommended. The condition may not affect the quality of the product, , regulatory compliance. The condition violates current GMP-rules. Recommendation for quality, safety or efficiency improvement. No GMP violation.

21/11/02

Page 7 of 7


				
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