Regulatory Focus™ > News Articles > FDA to Drug Manufacturers: Beware Water-Borne Contaminants

FDA to Drug Manufacturers: Beware Water-Borne Contaminants

Posted 22 May 2017 | By Zachary Brennan 

FDA to Drug Manufacturers: Beware Water-Borne Contaminants

With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose.

“BCC can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents,” FDA said in a statement. “Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains.”

According to FDA, people exposed to BCC are at an increased risk for illness or infection, especially patients with compromised immune systems.

Recent Recalls

In October 2016, an FDA investigation identified BCC in more than 10 lots of oral liquid docusate sodium produced by Florida-based contract manufacturer PharmaTech, which found the contaminant in its water system. PharmaTech voluntarily recalled all its liquid products from 20 October 2015 through 15 July 2016 as a precautionary measure.

The US Centers for Disease Control and Prevention (CDC) confirmed 60 cases of BCC infection in eight states.

In August 2016, Sage Products also voluntarily recalled one lot of its Comfort Shield Barrier Cream Cloths, which treat and prevent moisture associated skin irritation, because of BCC contamination.

What to Do

FDA is specifically reminding drug manufacturers to:

  • “Establish procedures designed to prevent objectionable microorganism contamination of non-sterile drug products, such as procedures to assure adequate quality of incoming materials, sanitary design, maintenance and cleaning of equipment, production and storage time limitations, and monitoring of environmental conditions (21 CFR 211.113(a)).
  • Use scientifically sound and appropriate acceptance criteria (e.g., USP Chapter <1111> Microbiological Examination of Non-sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use)8 and test procedures (e.g., USP <61>/<62> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests and Tests for Specified Microorganisms, respectively) to assure that drug product components (including pharmaceutical water) and finished drug products conform to appropriate quality standards (21 CFR 211.160(b)).
  • Provide appropriate drug product specifications (tests, methods, and acceptance criteria) in applications submitted to the FDA (21 CFR 314.50(d)(1) for new drug applications, or 21 CFR 314.94(a)(9) for abbreviated new drug applications). As appropriate, additional laboratory tests may be needed to determine whether products are suitable for release.
  • Ensure that the methods used to test finished drug products prior to release for distribution are appropriately validated, accurate, sensitive, specific and reproducible (21 CFR 211.165).
  • Test in-process materials during the production process (e.g., at commencement or completion of significant phases, or after storage for long periods), using valid in-process specifications to assure, among other things, that the drug product will meet its final specification, including criteria for absence of microbial contamination, where appropriate (21 CFR 211.110).
  • Investigate any failure to meet specifications, including other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy (21 CFR 211.192), and implement appropriate corrective and follow-up actions to prevent recurrence.”

FDA Statement


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