Customer Reviews

Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations

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

 

 

The book is excellent. I only wish I had it 3 years ago when I started in QA. It is a basics book. There isnt a lot of detail but it is a good frame work for starting a regulated or soon to be regulated company.

I'm in a Good Manufacturing Practices environment and my manager, the head of Manufacturing Quality Assurance, kept mentioning this book and referencing it in her Standard Operating Procedure documents. It's expensive, but it is a textbook and a reference book. This book has been the gold standard for 20 years or so. You'll want to read through it completely. Then, after that, it is good reading to keep in your car or work desk for those times when you have a few minutes to spare. Keep reviewing the information to stay fresh. This is a recent edition with update for Quality standards.

Don't talk about it over pizza and beer with your friends on Friday night though. It probably won't help you get a date!!

This is a mixed review. The content is good. It could be organized a little more clearly. I was, and continue to be, very disappointed that there is no index. Especially at this price point, I would expect a technical reference book to be well indexed.

Content is a good primer and reference for entry level people in the business as well as for students. The text covers a good amount of topics, but while the content that it does have is good, it is sparse on details. For example, "SOP Review and Approval" has a one paragraph description.

Pros
The content that is there is good
Good coverage of topics
Some sample documents

Cons
Price
No index
Content is sparse
Organization is so-so

Very good, complete documentation for cGMP requirements. Useful for newly minted QA/QC departments and a great reference for those with experience.