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Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Medicines and Healthcare Products Regulatory Agency (Autor)

Media-Kombination

432 Seiten

2007 | Revised edition
Pharmaceutical Press
978-0-85369-721-3 (ISBN)

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Familiarly known as the "Orange Guide," this title combines the major pharmaceutical Regulations, Directives and guidance, which wholesalers and the pharmaceutical industry use as their main source when manufacturing and distributing medicinal products in the EU.

* EC Guides to Good Manufacturing Practice and Good Distribution Practice; * EC Directives on Manufacture, Wholesale Distribution and Good Manufacturing Practice; * Code of Practice for Qualified Persons and Guidance for Responsible Persons; * Standard Provision for Manufacturer's Licences; * Standard Provision for Wholesale dealer's Licences; * Guidance on Reporting Defective Medicines; * Voluntary Inspections for Good (Research) Clinical Practice and Manufacture of Active Pharmaceutical Ingredients.

Erscheint lt. Verlag	13.2.2007
Verlagsort	London
Sprache	englisch
Maße	172 x 244 mm
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
ISBN-10	0-85369-721-3 / 0853697213
ISBN-13	978-0-85369-721-3 / 9780853697213
Zustand	Neuware