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In the wake of recent product recalls, FDA is advising drug manufacturers of non-sterile, water-based drug products on the risks of Burkholderia cepacia complex (BCC) contamination. BCC is resistant to certain preservatives and antimicrobial agents and is among the contaminants that can be found in pharmaceutical water systems, as are other water-borne opportunistic pathogens. Detecting BCC is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different strains.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
