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Resource Center For GMP Auditors
As an auditor in an industry regulated by FDA, you have a very important responsibility for the overall quality of the goods your company produces. We have set up this resource center to help you do your job better.
Articles on GMP Auditing
Preparing for an Audit
This article discusses 9 steps to take to help you prepare for a successful audit.Using Checklists in GMP Auditing
This article discusses the advantages and disadvantages of using checklists in auditing, and how to optimize the advantages and minimize the disadvantages.
Audit Checklists - based on GMP Institute Framework
These links provide generic checklists for auditors performing GMP audits. Before using these, be sure to read the article above entitled "Using Checklists In GMP Auditing."
Drug Industry (large file - may take several seconds to load.)
Medical Device Industry - see FDA's QSIT
Are you feeling overwhelmed by the prospect of conducting an audit? This graphic may help you to plan out a process which is manageable. It demonstrates a generic model which you can adopt and adapt as you need to.
Support Groups and Other Resources for Auditors
Assignments for Auditor Certification Participants
These are no longer available on this site. If you are enrolled in the auditor certification program, you can find the assignments under your e-community at www.ispe.org, or you can send an email to gmpcert@ispe.org .
