ENGLISH

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

By John Sharp

Book information

Publisher
Informa Healthcare
Year
2004
ISBN
0849319943, 9780849319945
LCC
RS189 .S524 2005
Open Library ID
OL22712187M
Language
english
Format
PDF
Filesize
5 MB (5411136 bytes)
Edition
1
Pages
515\515
Library
mexmat
Time added
2009-11-09 02:42:13
Медицинские дисциплины;Фармацевтика;Фармацевтическ

Description

Bridging the gap between US regulations and European Good Manufacturing Practice guidelines, Sharp (European Journal of Parenteral and Pharmaceutical Sciences) explains the essence of material from the US 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). He compares the principal requirements in both systems, and explores the reasoning behind these requirements outlines ways to comply with them. Coverage encompasses personnel and facilities management as well as manufacturing. The book will be useful for those who wish to expand their pharmaceutical business

Similar books