Customer Reviews

Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to US, European, and ISO Requirements

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This book provides extensive information for specialists in companies that have to comply with FDA regulations. It also has some good information on auditing that will be useful to quality engineers and auditors with limited experience in International Organization for Standardization (ISO), Food and Drug Administration (FDA), Code of Federal Regulations (CFR) and Good Manufacturing Practices (GMP) requirements. CFR standards are tough. Compliance with them, following the lead of this book, should help a company comply with the ISO standards. Companies that comply with the ISO standards, however, might not comply with the CFR requirements This book leads the reader through a series of steps that will help the company meet CFR requirements. It goes into extensive detail identifying and interpreting the various CFRs so that the readers will not take them too lightly. Some CFRs are much too vague and can lull newcomers to the field into thinking that they are in compliance when they are not. I would have rated this book as a 5 except that only a limited number of quality practitioners have a need for this material on GMP compliance. Hank Lefevre, CQE & PE