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GMP Publications, Inc.

Food & Drug Administration (FDA)
 U.S. FDA Code of Federal Regulations & EU ICH Handbooks
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Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

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NEW - US - Canadian and ICH GMP Guidelines!

Health Products and Food Branch Inspectorate

GOOD MANUFACTURING PRACTICES (GMP) - GUIDELINES

Starts at $7.90 each. - 2009 EDITION - GUI-0001
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These guidelines on Good Manufacturing Practices (GMP) pertain to Division 2, Part C of the Food and Drug Regulations. The guidelines apply to pharmaceutical, radiopharmaceutical, biological, and veterinary drugs and were developed by Health Canada in consultation with stakeholders. These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.

Supersedes: 2002 Edition, Version 2
Date issued: May 8, 2009
Date of implementation: November 8, 2009

 

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GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com