For drugmakers, complying with FDA current GMP requirements is job one. But putting your hands on all the regulations, guidances, notices and interpretations that — taken as a whole — make up the GMP requirements is a challenge.

Drafted and implemented at different times over decades, the collection of documents that implement today’s GMP requirements have been widely scattered online and at federal depositor libraries — until now.

For the first time, we’ve brought together all the official references that make up the GMP requirements in one comprehensive resource.

The Guide to FDA Pharma GMP Regulations – 2011 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 us for. In it, you get the current text of the FDA’s GMP regulations for drugs and biologics, with Federal Register announcements and 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.

We’ve literally spent hundreds of hours finding many of these documents on obscure websites and more that aren’t even online. 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 vendor laboratories
• Employee qualifications
• Individual liability for adulterated products
• Storage of quarantined product
• Cleaning validation
• Acceptance testing
• Stability testing
• 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, if they’re posted at all.

But now you can install them all on your desktop, just a click away whenever you need to add context and background to the latest changes to GMP requirements and regulations.

Finally, you’ll have all the information you need to fully understand, interpret and follow the federal rules and standards that the FDA uses to regulate your manufacturing processes and practices.

Up-to-date, comprehensive and organized for easy reference, Guide to FDA Pharma GMP Regulations – 2011 is the answer to all of your toughest GMP questions.

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