26-29 September 2023
Barcelona, Spain
On 22 May, the FDA advised drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products. The publication was based on recent product recalls due to Burkholderia cepacia complex (BCC or B. cepacia) contaminations. Non-sterile aqueous drug products and parts of water systems may potentially be contaminated with organisms in the Burkholderia cepacia complex (BCC). BCC strains have a well-documented ability to ferment a wide variety of substrates and are known to proliferate in the presence of many traditional preservative systems. Thus, despite the presence of otherwise adequate preservative systems, BCC strains can survive and even proliferate in product during storage.
The recent recalls and the fact, that an exposure to BCC can increase the risk of illness or infection now induced the FDA to remind drug manufacturers of non sterile products to establish suitable methods to prevent objectionable microorganisms contamination considering the requirements of the 21CFR 211 "CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS" and 21CFR 314 "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG" .
The requirements have been described several times in FDA's Microbiology/Virology Reviews and in presentations from FDA representatives - e.g. at the European Microbiology Conference in May 2017 as follows:
Furthermore, it is of importance, that any kind of adverse events or contaminations are immediately reported to the responsible FDA office. Concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application it should be reported with 21 CFR:NDA Field Alert Report and/or reported to FDA’s MedWatch Adverse Event Reporting .
More details can be found at "FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products"