GMP Inspection Preparation Checklist: A Tool for Internal Auditing

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GMP Inspection Preparation Checklist
A Tool for Internal Auditing

Would you like to make your next regulatory inspection less stressful?

It’s possible with this comprehensive checklist of questions investigators typically ask — it’s the ultimate cheat sheet for your 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 includes more than 650 items organized in three sections covering all aspects of quality manufacturing, including:

  • General questions for manufacturers of medicinal products and APIs — questions on sanitation, equipment, materials controls, validation, documentation, change control and more

  • Manufacturing and testing of sterile products — questions on aseptic processes, sterilization methods and sterility testing

  • Active pharmaceutical ingredients

You 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 you spot and fix problems before your next inspection

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

Order Your Copy Today

PDF Edition

 

Available Format

PDF Edition — $230

About the Authors

Max Lazar, Chemist, FDA Regulatory Compliance Consulting
Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organizations and chairs of committees. 

Christine Oechslein, Pharmacist, GMP-Praxis
As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organizers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.

Bernhard Gotter, Pharmacist, F. Hoffman-La Roche, Ltd.
Bernhard Gotter took up the position of QA Manager in inspection management at F. Hoffmann-La Roche in 2016. In the previous five years, he had worked at Bayer in quality assurance, auditing, supplier management and project management. During this time, he managed numerous audits, and organized and supported official inspections.

Who Will Benefit

  • Quality control department
  • Regulatory compliance department
  • Auditors
  • Consultants

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