Автор: Joseph D. Nally
Название: Good Manufacturing Practices for Pharmaceuticals, 6th Edition
Издательство: CRC Press
Год: 2006
ISBN: 9780849339721
Серия: Drugs and the Pharmaceutical Sciences (Book 169)
Язык: English
Формат: pdf
Размер: 16,7 mb
Страниц: 424
The world of Pharmaceutical CGMP compliance has certainly evolved since the 5th edition of this book was published about six years ago. We are now living in the post 9-11 era; national and global pharmaceutical business consolidations and expansions are continuing at a brisk pace; the FDA Is changing its approach to regulating manufacturers; global harmonization of regulatory requirement and quality standards has been accelerated; availability and access to internet sources of information has exploded and counterfeiting and bioterrorism are part of the daily dialogue.
There is more dialogue and science based regulations/approaches appear to be the future. The chances of being inspected are less but if non-compliance is found during an inspection, the penalties are going to be more severe. This is especially true for firms having a history of repeat observations or recidivist behaviors.
This brings back to this book. This text is invaluable for anyone directly involved in pharmaceutical manufacturing and control operations. It is also essential for GMP and quality auditors (private industry and government), quality assurance and control professionals, contractors and suppliers to the industry, industry consultants, pharmacy and pharmaceutical science educators.