Sunday, April 17, 2011

Current Pharmaceutical Industry CGMP Compliance Trends

It must be that time of year again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry.

So with this edition I offer my opinion not only to those conference planners, but also to my readers. After all, why should you—my loyal readers—have to attend a pricey conference to hear what I told them?

But first, a note about—well, these pricey pharmaceutical conferences.

There are worthwhile conferences in our industry, but you really have to consider whether they are worth the price of admission. I have always thought that the best conferences were those with a strong FDA presence on the speaker roster. However, FDA speaker materials eventually become accessible to the general public. So, shortly thereafter, you can Google the name of the FDA speaker you saw in the pre-conference e-brochure and bingo. If it’s content you’re after, why not use your favorite search engine?

The worst conferences are those that recycle the same industry consultants—free advertisement. I'll save that subject for another time.

So—now to the subject at hand: current pharmaceutical industry CGMP compliance trends. Here are the top three, in my opinion:

1.    There is an emboldened FDA intent on measuring up under a keenly interested Congress.

·       There are sixteen (16) major pharma consent decrees dating from 1989 to 2010. What do they all have in common? No, it’s not bodies in the street. It’s GMP violations. Of these, only six (6) consent decrees have been vacated.
·       Eric Blumberg, FDA Chief Deputy Counsel for Litigation, has been saying for the last ten (10) years that the FDA cannot expect progress until individuals are criminally charged. We’re starting to see that now. (Enter stage left: KV’s Marc Herelin, InterMune’s W. Scott Harkonen, Forrest’s Solomon, Glaxo’s Lauren Stevens.)
·       Margaret Hamburg, FDA Commissioner, said that the FDA will no longer issue multiple Warning Letters. Criteria have been developed for selecting cases for criminal prosecution of individuals.

2.    When there are repeated observations, the FDA questions the willingness and ability of the Quality Unit to exercise its responsibility.

·       Repeated FDA483 observations are considered a failure of the Quality Unit, as stated in numerous Warning Letters.
·       Warning Letter language recognizes that Quality Unit failure may be attributed to either an unwillingness to exercise its responsibility, or an inability due to lack of independence.
·       Recent high-profile cases have ineffective quality units in common.

3.    FDA expects the global deployment of the Quality Management System and oversight by corporate management.

·       Corporations are expected to have oversight of the quality and regulatory compliance of their operating units.
·       Some companies have “flattened” their organizations into non-compliance and lack of oversight upon the questionable advice of efficiency and cost-reduction experts.
·       The Parke Doctrine holds management responsible although they may not have been directly involved or aware of violative conditions. Some of these individuals have appeared before Congress.

Now, here’s the funny thing. One conference planner asked if this anonymous blogger would agree to be a speaker. What part of “anonymous” didn’t they understand?

Perhaps I could make it work? Perhaps a backlit screen projecting my trademark silhouette?

John Snyder
The QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.

John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.

Contact us at


  1. I like to ask a question on cGMPs. How can I make my management understand the need for compliance to cGMPs in Phase 1 studies and evaluating the manufacturing by auditing rather than accepting the COA/CMC section? Is there any citation/refernce by FDA that a "sponsor" requires to evaluate the manufacturer/product prior to signing off on Form 1571, even though the signer is a government organization?

  2. From one Anonymous to another,,,

    Compliance with CGMP regulations are applicable for approved drugs and investigational new drugs for administration to humans or animals. Check out the Commissioner's responses to question #49 in the GMP Preamble:

    "The Commissioner finds that, as stated in 211.1, these CGMP regulations apply to the preparation of any drug product for administration to humans or animals, including those still in investigational stages."

    "...the process by which a drug product is manufactured in the development phase be well documented and controlled."

    As I am sure you appreciate, you can't fulfill this solely by a perfunctory review of a COA.

    Government Agencies do not get a "pass" on this. Heck...the American Red Cross was chartered by Congress. They're still under an FDA Consent Decree.

    Hope this helps. Let me know.
    The QA Pharm

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  4. Thank you, Chris. Welcome.

    The QA Pharm

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