Validation Standard Operating Procedures

Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition Sad – this book could have used an Editor – cousette copeland – santa clara, california USA
First of all – no index.
Second – the CD has examples that are poorly and inconsistently formatted. To use them, you’d have to spend time formatting everything. They should have used fonts, styles, etc. that are used in standard documents.
Thirdly – the book is huge so you’d expect more information on what to put in a Purpose, a Scope, etc. You don’t get that. Instead you get a bunch of examples that must have been pulled from one or two companies.
If you are a professional writer like me, you don’t want to waste time. You want something in template format that you can easily adapt to your company’s product.
If there had been a review of this – I never would have bought it. I’m sorry but this book could have used an Editor. It was so disappointing and I’m so happy that Amazon understood my feelings and accepted the return of this book.
For a potential writer – here is a market! There are startup or small biotech/biomed companies that are trying to meet FDA regulations on SOPs and other related documents. Write a book and provide a CD with decent templates and examples! Hey, maybe I should do that. Good luck. I haven’t found any other book that would help either….
: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.