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Rules and guidance for pharmaceutical manufactures and distributors 2007

Author: Great Britain. Medicines and Healthcare products Regulatory Agency. Inspection and Standards Division.
Publisher: London ; Chicago : Pharmaceutical Press, 2007.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
Offering guidance to manufacturers of pharmaceutical products, this text brings together the latest pharmaceutical regulations, directives and guidance on a number of key issues.
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Genre/Form: Guideline
Legislation
Document Type: Book
All Authors / Contributors: Great Britain. Medicines and Healthcare products Regulatory Agency. Inspection and Standards Division.
ISBN: 9780853697190 0853697191
OCLC Number: 85332635
Notes: Includes index.
Description: xviii, 430 pages ; 25 cm
Contents: * 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.
Responsibility: compiled by the Inspection and Standards Division of the Medicines and Healthcare products Regulatory Agency.

Abstract:

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  Read more...

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