Guide to FDA Pharma GMP Regulations

Guide to FDA Pharma GMP Regulations 2014

September 2013

When is a drug repackager or relabeler subject to GMPs and when is it not?
What is the quality control unit’s ultimate responsibility for approval or rejection of materials?
What is required to satisfy GMP “continuing training requirements” and who do these apply to?
When products must be kept in separate areas, how should you define separate?
Must incoming water obtained from municipal water supplies be tested for purity?

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

For drugmakers, complying with FDA current GMP requirements is mandatory, but since the regulations were all drafted and implemented at different times over decades, the collection of documents that implement today’s GMP requirements have been widely scattered. Until now.

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 – 2014 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
  • Quality control unit responsibilities
  • Responsibilities for oversight of contract manufacturers
  • Employee qualifications
  • Individual liability for adulterated products
  • 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 – 2014 is the answer to all of your toughest GMP questions.

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