FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination

FDA has been sharpening its focus on water systems during inspections of nonsterile liquid products as microbial contamination problems of significance in these products continue to surface.

Of particular concern has been the number of serious contamination incidents among nonsterile products involving Burkholderia cepacia – a bacteria that is not always impacted by commonly used antimicrobial preservatives, can be difficult to detect, and can cause serious adverse health impacts on patients.

FDA investigators are looking to make sure that water systems are being controlled that come into play in the nonsterile as well as sterile production context, and that adequate testing and trending of data is being done to catch problems before contaminated products are distributed.

At the 2018 PDA/FDA conference in late September, Stephen Langille, who was then the Acting Director of the Division of Microbiology Assessment within the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ), provided a “regulatory perspective” on the control of pharmaceutical water systems.  Langille left the agency in February after almost 20 years and is now a consultant with ValSource.

At the conference, he reviewed: ● significant points, quotes, and nuances pertaining to water systems in the relevant USP and FDA standards, guides, and regulations ● the challenges around detection and control of B. cepacia complex (Bcc) organisms, and ● the problems and related recalls that have been surfacing.

In the latter part of the talk, he focused, in particular, on a nationwide 2016 Bcc contamination outbreak and investigation, which involved FDA, the Centers for Disease Control (CDC), and state boards of health. Found to have resulted from a Bcc-contaminated stool softener, the outbreak is highly revealing of the challenges involved in uncovering the causes and addressing the dire consequences of contaminated products stemming from inadequate water system controls.

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