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The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.
FDA warned drug manufacturers on May 22, 2017 about a series of product recalls involving Burkholderia cepacia complex (BCC) contamination. BCC is a water-borne pathogen that can be found in pharmaceutical water systems. According to FDA, it can be a challenge to detect BCC, and validated testing methods should take the “unique characteristics of different BCC strains” into consideration.
The agency is asking that manufacturers establish procedures (e.g., sanitary design, equipment cleaning, environmental monitoring) to prevent contamination of non-sterile drug products. Scientifically sound acceptance criteria and test procedures should be used to ensure quality, and new drug applications submitted to FDA should provide drug product specifications. Testing of finished drug products prior to release should be “validated, accurate, sensitive, specific and reproducible” according to 21 Code of Federal Regulations 211.265. In-process materials should be tested during the production process using valid in-process specifications, and finally, manufacturers should investigate any specification failures and implement corrective actions and preventive actions.