With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics 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.
Monday, August 22, 2011
Important Links
Today's Visitors
Search Books and Material
Contact Us
Popular Posts
-
The science and technology associated with pharmacy has progressed enormously over the past few decades. Significant ad...
-
Hitesh B.Katariya Gujarat, India. E mail id: a dmin@pharmagupshup.in pharmagupshup@gmail.com Mobile No: +91 999...
-
pharmaceutical Journals & Magazines Academic Medicine Academic Medicine is the official, peer-reviewed journal of...
-
Good Manufacturing Practices for Pharmaceuticals, Sixth Edition With global harmonization of regulatory requirements and quality standards...
-
Lisa Henderson For the post-surgery patient in recovery, the drug addict in ER, late-stage cancer patients, and the many who suffer ...
0 comments:
Post a Comment