Guide to FDA Pharma GMP Regulations - 2015

February 2015
Is your quality data adequately protected from unauthorized access?
Can your manufacturing records pass the scrutiny of an FDA inspection?
Are your SOPs easy to follow and do they accurately reflect GMPs?

What are the answers to these questions? The FDA knows, and it expects you to know, too.

FDAnews has brought together all the official references that make up the GMP requirements in one comprehensive resource.

The Guide to FDA Pharma GMP Regulations – 2015 is a compilation of pharmaceutical GMP regulations that puts all the authoritative information you need in one place.

Delivered on CD, this comprehensive, all-electronic reference is just what drugmakers have been asking for. In it, you get the current text of the FDA’s GMP regulations for drugs, biologics and combination products with Federal Register announcements and hard-to-find background information, plus the guidance that helps you maintain compliance. These documents are a gold mine for anyone who has to determine whether they are complying with GMP rules.

We’ve literally spent hundreds of hours tracking down many of these documents on obscure websites and in musty libraries. But the hunt has been well worth it.

Buried in these notices of rulemaking and guidances, you’ll find the full explanations of why the FDA has written the rules the way it has, touching on all aspects of pharma GMPs and adding perspective to the FDA’s thinking on a host of issues, including:

  • Labeling and expiration dating
  • Maintaining proper documentation and SOPs
  • Data integrity
  • Quality control unit responsibilities
  • Responsibilities for oversight of contract manufacturers
  • Storage of quarantined product
  • Cleaning validation
  • Acceptance testing
  • Stability testing
  • Combination products
  • Many other issues drugmakers must deal with daily.

Until now, much of this information has been lost over time or relegated to hard-to-find corners of government websites and federal depository libraries.

But now you can install them all on your desktop, just a click away whenever you need to really understand GMP requirements and regulations.

Up-to-date, comprehensive and organized for easy reference, Guide to FDA Pharma GMP Regulations – 2015 is the answer to all of your toughest GMP questions.

Order Your Copy Today!


Available Format

CD – $377

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Table of Contents

  • Section I—cGMP Regulations for Drugs
  • Section II—cGMP Regulations for Biologics
  • Section III—Regulations for Combination Product Jurisdiction
  • Section IV—cGMP Guidelines from the International Conference on Harmonization
  • And More …

View the entire TOC

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