Handbook of SOPs for Good Clinical Practice, Second Edition Review

Average Reviews:

(More customer reviews)The need for writing and implementing effective SOPs in a whole spectrum of fields is on an exponential rise. Unfortuntely, there aren't many SOP books available in the market. This book by Celine Clive is one of a very few fine books on SOPs. It provides quite a few ready to go SOP templates in the clinical field. The templates seem to be consistent with the International standards. The List of SOPs covered include Spnosor/monitor/CRO SOPs, Investigational site SOPs, and Institutional Rebiew Board SOPs. The book also includes some useful forms in the clinical industy. One thing that may concern the reader is that the book is priced very high.
Again, the book is focussed on the clinical industry. If you want a book to learn the basics of writing and implementing effective SOPs that could be applied to any field, begin with the following book:
SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries
If you are a beginner in the field of SOPs, this book by Dr. Paul Sanghera is your book. It explains the basic SOP concepts from scratch and offers simple examples, exercises, and templates. It's a general book on SOPs that can be used by any reader in any field. It's a good starting point for any professional in any field who wants to start with writing and implementing effective SOPs. Topics covered include: Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms. I specifically like the process based approach to SOPs: very innovative and useful approach. The price is right.
After this book, you can use the book by Celine Clive reviewed above if you are in the clinical field. There is also another good book on SOPs reviewed below:
SOP Guidelines
This book by D.H. Shah covers SOPs in quite a few areas including Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. It also contains SOP templates in these fields. A good collection of SOPs on Tablets & Capsules, Ointments, Quality Control, Liquid Orals, and Sterile Preparations. The book is highly priced, but useful.




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Completely revised and updated, this second edition of a classic handbook provides templates of SOPs ready for immediate adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that readers can easily modify the text to reflect their organization's processes. The language ranges from the specific to the very general, depending on the activity described and the number of the existing regulations governing it. The handbook gives readers a starting point for the development of their company or institution's SOPs.

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