Customer Reviews

Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance

5 star:		(1)
4 star:		(0)
3 star:		(0)
2 star:		(0)
1 star:		(2)

 

 

I'm sorry to report that this book merely presents an outline of steps to take, along with a collection of document templates, neither of which contain any actual "content". In other words, it tells you "what", but not "how". If you're looking for insight and real-world examples, look elsewhere. I couldn't justify a bunch of blank forms and outlines for such a cover-price. I sent mine back and Amazon graciously refunded my money.

This book may be just as the Author intended, an outline of how to set things in motion. AND, that is all that this is. Don't fool around with this one... you'd be better off going to the FDA site for their guidelines.

The CD is a jokingly filled example of templates that waste your time and you have to put more energy into them to configure for your uses.

ALSO, there really is NO MASTER VALIDATION PLAN within this. It's a poor example of going about things. It may seem clear, but there is no flow to it whatsoever and it is confusing.

I've been in this field of Validation and MVP and medical for yrars... this is a pure MESS. Soon, I might write a real book.

I have reviewed this excellent book. This book guides you through all process required for validation from FDA. In new edition, the author should give more details and technical guidance for control systems and software validation. Also to help in 21 CFR 11 approval. CD-ROM with the book is a help to cut down all the time wasted in formatting information and make templtes for crtical forms. Congratulations for writing this exceelent book.