A Tool for Internal Auditing


GMP Inspection Preparation Checklist:

A Tool for Internal Auditing

**An FDAnews Management Report**


Drugmakers, don’t be stressed out for the next inspection. This comprehensive checklist of questions investigators typically ask is the ultimate cheat sheet for the next inspection.

The checklist is designed for internal audits, to prepare staff to answer investigator questions, and to spot and correct mistakes before the investigators ever arrive.

GMP Inspection Preparation Checklist: A Tool for Internal Auditing is written by three industry experts with more than 75 years of combined GMP experience. Max Lazar (chemist) founded a consulting business specializing in API GMP issues and personnel training covering the ICH Q7 guidance. Christine Oechslein (pharmacist) provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. And Bernhard Gotter (pharmacist) is the QA Manager in inspection management at F. Hoffmann-La Roche and also has experience in auditing, supplier management and project management.

The report includes more than 650 items organized in three sections covering all aspects of quality manufacturing. Readers will learn:

  •     How GMP terms and ISO language can differ and how to reconcile them
  •     The CFR and EU GMP references related to each quality requirement
  •     How to conduct mock inspections
  •     How using a GMP checklist can help spot and fix problems before the next inspection

Order GMP Inspection Preparation Checklist and know the kinds of questions regulatory investigators ask and have the opportunity to practice answering them.


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