The cGMP Plant Design, Commissioning and Qualification

ISBN-13: 9783330057913 / Angielski / Miękka / 2017 / 200 str.

Nikhil C. Saha

Opis

The purpose of this book is to establish a standard guideline based on CGMP for the GMP regulated industries in the Company wide successful implementation of Capital Projects. This guideline provides a consistent and uniform approach to executing all Capital Projects. All Capital Projects should be planned, coordinated, documented and executed in an efficient manner, utilizing the best practices outlined by this guideline. It would have a significant impact in the GMP regulated industries globally. This is a readily available proven standard, which would be followed for consistency. Establishing a new standard by projects is time consuming and costs a fortune, and company may have to absorb a significant opportunity cost if it is recognized less than ideal by the regulatory authorities. A proven, regulatory authority accepted readily available CGMP standard would help the company to maintain a stable business. It will open a new horizon in the GMP regulated industries globally. This standard guideline is for the GMP/CGMP regulated industries, obviously, it would be very much beneficial for the GEP for other industries globally as well to maximize the quality and minimize the costs.

O autorze

Dr. Nikhil C Saha has BS, MS and Ph.D. in Chemical Engineering, and MBA. Dr. Saha has been a multi-states licensed P.E. (Professional Engineer), experienced engineer with over 20 years in the pharmaceuticals, bio-technologies, medical devices, chemicals, and other industries. Dr. Saha is the author of several articles published in reputed journals.