GMP Audit Resources

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Considerations in GMP Auditing
Covers some of the basic considerations for GMP auditors to review.

Using GMP Checklists In GMP Auditing
Discusses the pros and cons of using checklists when conducting GMP audits, and how to use them most effectively.

GMP Audit Checklist For Drug Manufacturers
A 7 page audit checklist, based on 21 CFR Parts 210 and 211, can be customized to use for an internal GMP audit.

Inspectional References
Presents information provided to FDA investigators and inspectors to assist them in their daily activities.  Some references included are:  Field Management Directives, Guides to Inspections, Investigations Operations Manual, Inspection Technical References, Medical Device GMP Reference Information, and QS Regulation/Design Controls.

Quality Systems Inspections Technique (QSIT)
This document was developed by FDA to create an inspection program covering the quality systems regulation, which results in more focused and efficient inspections. It helps FDA investigators focus in on key manufacturing and quality areas at the manufacturer during inspections, in order to determine their state of compliance with the Quality Systems Regulation.  

Compliance Program Guidance Manual For FDA Staff: Drug Manufacturing Inspections
Provides guidance for evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.

Australian Resources For GMP Audits
Material published by TGA on how to manage audits.

Last Update: 27 October 2011

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