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Manufacture Quality & Compliance, Standards & Regulation, Facilities

Turning Failure into Success

As Albert Einstein once said, “The person who never made a mistake never tried anything new.” But mistakes in the pharma industry can have serious consequences for patients, which is no doubt one of the reasons the industry can be cautious – it’s simply a case of following the inverse of Einstein’s wisdom! In reality, not moving with the times can also be an error – outdated facilities or processes can become risk hazards in the eyes of regulators.

Warning letters from the FDA or other agencies are a fact of life in the pharma industry. After all, no facility, process or employee is perfect. Warning letters are publicly available, but the recipients do not like to draw attention to them and remedial action is usually taken quietly. Once uncovered by a journalist in search of a new headline, however, warning letters become very public – and very quickly.

One incident that made headlines in 2015 was a warning letter received by the US National Institutes of Health about its Pharmaceutical Development Section (PDS) and its intravenous admixture unit (IVAU) in Bethesda (1). The letter contained an extensive list of problems.

The subsequent remedial action – the most important part of the ongoing story – was not widely reported, as is often the case. In fact, the NIH pulled together a task force and asked a contract organization for an independent assessment and suggested actions (2). Specific areas of focus included air handling, deficiencies in the facility and equipment, training, standard operating procedures and quality control. The main problem appears to be that the facility was simply out of date; a major rebuild is required to bring it up to speed with cGMP. Ongoing drug production at the PDS has been decommissioned for some time. As for the IVAU, a number of actions have been taken, which were acknowledged by the FDA in a July 2016 letter (3).

Journalists often focus on negativity – perhaps leaning towards the schadenfreude of their readers. But with every industry ‘scandal’ there are lessons to be learned. By focusing on the solutions to problems – and celebrating innovations that reduce risks or improve processes – we can all move forward; hopefully, with fewer mistakes.

To that end, I’d like to draw your attention to our annual Innovation Awards, which will be published in our December 2016 issue. Nominations are now being accepted at And, as proved by our cover feature in this issue, innovation isn’t possible without special people – nominations for our 2017 Power List ( are also open.

Stephanie Sutton

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  1. FDA, Letter Sent to Mr Robert DeChristoforo, Chief, Pharmacy Department at the NIH – Clinical Pharmacy Center (2015). Available at: Accessed August 10, 2016.
  2. NIH, “Report from NIH Task Force on the Clinical Center Pharmaceutical Development Section (PDS)”, (2015). Available at: Accessed August 10, 2016.
  3. FDA, Letter Sent to Dr Barry R Goldspiel, Acting Chief, Pharmacy Department at the NIH (2016). Available at: Accessed August 10, 2016.
About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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