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gibraltar BLOG ARCHIVE

FDA Auditing – Prepare Yourself with the Help of Gibraltar Laboratories Inc.

By: Daniel Prince

Proper testing is more important than ever.  Regardless of marketing and anything else, the only way to be fully compliant with the FDA is to have an effective drug.  Regardless of how powerful your fiduciary backing is and how prolific your marketing team is, without proper testing and research your product is as good as dust.

The FDA is constantly updating and auditing themselves along with anyone they do business with.  Their rules are strict, and their agents are the sharpest in the world.  Prepare yourself for the most rigorous and unforgiving inspections and auditing processes possible if you intend to have anything approved, period.

In November of 2014 alone the FDA was responsible for auditing, testing and approving dozens of products.  Check out this list about November 2014 on the FDA’s website.   Further observation of this data shows that many of these recorded approvals are for labeling revisions and manufacturing changes or additions.  Even after having a product approved, pharmaceutical industries need to be on top of researching drug efficacy as well as updating manufacturing facilities, keeping them within sanitary and other regulatory guidelines.

Finding the right CRO will mean the difference between approval or failed clinical trials.    Look at the FDA’s Introduction to New Drug Applications for Pharmaceutical and other research and medical device production organizations.  Approval doesn’t come easily, especially if your pharmaceutical company desires approval for orally administered drugs.  Pharmaceutical or otherwise, at some point in time a research organization will need to be either constructed or contracted.  Make no mistake—the NDA is comprised of hundreds of “guidance documents” that are reviewed with a fine-toothed comb by medical experts.  They don’t write themselves.

Prepare yourself for a wide range of submissions, applications, guidance documents, referrals, revisions, clinical trials, experiments and more.  Don’t forget that the most important part of production is making sure that the product is effective and safe to administer.  Sanitation and validation are as important as the product itself, as it ensures the safety of a medical product.

There’s nobody out there that wants their product to fail after passing rigorous clinical trials, because of impractical or ineffective storage and sterilization.  Proper validation of sterilization is integral to continued FDA approval of sterile products.  It’s imperative that every product is treated equally in the area of sterilization practices.

Between September and October of 1937 Elixir Sulfanilamide killed over 100 children in the United States.  It “tasted great”, but poor research allowed companies to market a deadly poison as cold medicine.  The FDA will never allow that to happen again.  Safeguard your institution by hiring a CRO like Gibraltar Laboratories, Inc.  Preparation for the FDA has never been more important.