John Sharp - Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

000ad93c_medium..jpg


John Sharp - Good Pharmaceutical Manufacturing Practice: Rationale and Compliance
Pages:288 | PDF | Interpharm Press Inc (30. Oktober 2004) | ISBN 0849319943 | 4.5 MB

Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, this book comparatively presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide). Based on the author's 40+ years experience, it offers special consideration of the reasoning behind the requirements, with specific regards to compliance methods. Topics also include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Link:
Hidden contents (Our Amazon affiliate links)
You must click 'Thank You' before you can see the data contained here. You can purchase this item from Amazon with discount through our amazon affiliate link.
BUT You DONOT have sufficient rights to see the hidden data contained here.
Please Register to see contents.