This book serves as an excellent resource for pharma, biotech, and medical device companies in EU regulatory compliance. The book adeptly covers basic requirements for medicinal products and for active substances used as starting materials along with Commission Directive 2003/94/EC, and EMEA GMP documents. Expertly written, this book is a very useful handbook for quality assurance and compliance teams for EU companies or foreign companies doing business in the EU. Good Manufacturing Practice (GMP) Guidelines: The Rules Governing Medicinal Products in the European Union, EudraLex Volume 4 Concise Reference
This book is an indispensable tool for anyone working in the quality assurance or regulatory affairs functions for pharmaceuticals, biotech, and medical device companies. Designed as both a critical textbook for training and an essential industry desk reference for those new to the field or experienced. Includes all updates and changes through December 2009.
European Union Regulations and Associated Guidance:
* Overview and Orientation
* Introduction
* Commission Directive 2003/94/EC
* Part I: Basic Requirements for Medicinal Products
* Part II: Basic Requirements for Active Substances used as Starting Materials
* Annexes 1 - 20 and the European Commission Glossary
EMEA (European Medicines Agency) GMP Documents:
* Inspections - Good Manufacturing Practice
* Quality Systems Framework for GMP Inspectorates
* Procedures Related to Rapid Alerts
* Procedures Related to GMP Inspections
* Forms Used by Regulators
* Procedures Related to Centralised Procedures
* Combined Glossary and Index - Medical Device - Pharmaceutical - Biotechnology - Compliance'
Detail Products
Detail Reviews
Click here for more information
