Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

NIH Permanently Closes Drug Production Facility For Clinical Trials

XTALKS VITALS NEWS

Albumin

The closure is part of a review of the NIH’s Clinical Center Pharmacy Department.

Tweetables from this article:

Tweet: The NIH used the PDS to manufacture drugs for use in Phase I and Phase II #clinicaltrials http://ctt.ec/qFlzv+The NIH used the PDS to manufacture drugs for use in Phase I and Phase II clinical trials.

Tweet: 2015 #FDA inspection found multiple cGMP violations at the Pharmaceutical Development Section of the #NIH http://ctt.ec/tb5aA+2015 FDA inspection found multiple cGMP violations at the Pharmaceutical Development Section of the NIH.

Share this!

August 15, 2016 | by Sarah Massey, M.Sc.

A facility used to manufacture drugs for early-stage clinical trials has been shut down by the National Institutes of Health (NIH), after an inspection found problems with the plant’s aseptic production practices. The closure is part of a review of the NIH’s Clinical Center Pharmacy Department.

An inspection conducted by the US Food and Drug Administration (FDA) in 2015, found multiple current good manufacturing practice (cGMP) violations at both the Pharmaceutical Development Section (PDS), and the Intravenous Admixture Unit (IVAU). Following the inspection, The NIH ceased production in the PDS, but the government agency has recently decided the permanently close the department.

The NIH used the PDS to manufacture drugs for use in Phase I and Phase II clinical trials. An interim IVAU has been established, with the NIH planning to move into the facility in October of this year.



One month before the FDA inspection, two vials of albumin were identified as contaminated with fungus. While the contaminated albumin was administered to patients as part of an interleukin experimental trial, no adverse events were reported.

The NIH was quick to address the violations by ceasing sterile production in the PDS, and employing outside firms to assess operations. Francis Collins, the director of the NIH, even went so far as to establish a new Office of Research Support and Compliance in late 2015.

After completing Phase 1 of its review, the NIH decided to permanently close the PDS in May of this year. “Phase 2 reviews begin this month and will look at instrumentation qualification, standard operating procedures and training, under the oversight of the newly established NIH Office of Research Support and Compliance,” said a spokesperson for the NIH.

As of yet, there are no plans for the NIH to reestablish the PDS. The agency says they plan to outsource the drug products they used to manufacture in the unit.

The FDA’s inspection found less serious violations in the NIH’s IVAU. “By the end of this calendar year, we expect a new interim Intravenous Admixture Unit (IVAU) to be operational,” said an NIH spokesperson.


Keywords: NIH, Clinical Trials, Drug Manufacturing


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Study Finds Hospital-Acquired Anemia Linked with Poorer Patient Outcomes

May 19, 2017 - New research conducted at UT Southwestern Medical Center has found that one in three patients admitted to hospital develop anemia as a result.

Featured In: Life Science News


Scott Gottlieb Takes the Helm of the FDA

May 18, 2017 - One of the first things on his regulatory agenda is to address drug pricing – a hot topic in the US pharmaceutical industry today.

Featured In: Pharmaceutical News


Opioid Prescriptions for Minor Injuries Contribute to Growing Epidemic

May 18, 2017 - While many assume that patients prescribed large quantities of opioid drugs – such as oxycodone – for chronic pain are at the highest risk of abuse and dependence, new research suggests that small prescriptions for these narcotic painkillers could be just as dangerous.

Featured In: Drug Safety News


LEAVE A COMMENT
 
  
THE XTALKS VITALS LIFE SCIENCE BLOG

Top 5 Most Impactful Tweets in Life Sciences During the Last Week

REGISTER FOR THESE WEBINARS

The ABCs of Assessing Cognition in Oncology Clinical Trials: Applications, Benefits, and Considerations


Respiratory Endpoints, Scientific Leadership and the Asia-Pacific Region


Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges


Enabling Patient-Centric Digital Transformation in Pharma and Biotech


Copyright © 2016-2017 Honeycomb Worldwide Inc.