Director, CMC Dow Development Labs Petaluma, California
FDA focus on Burkholderia cepacia complex (BCC) has increased in the past year. An FDA guidance was issued,“Microbiological Quality Considerations in Non-Sterile Drug Manufacturing” published in September 2021 which was updated to include BCC. In addition, an FDA advisory to drug manufacturers in April 2023 states that BCC poses a contamination risk in non-sterile, water-based drug products. More recently the projected update of USP < 3> Topical and Transdermal Drug Product – Product Quality Test – scheduled for August 2023 includes USP < 60> testing for Microbiological Examination of Nonsterile Products- Tests for BCC. This presentation discusses what these guidelines mean for non-sterile manufacturing, the risk factors involved, and a risk-based approach to minimize BCC contamination during the manufacturing of nonsterile drug products.
Learning Objectives:
Upon completion, participant will understand what Burkholderia cepacia complex (BCC) is, the FDA's stance on BCC, the BCC risk factors, and how to minimize BCC contamination in manufacturing.
Upon completion, participant will be able to understand the role water plays in BCC contamination.
Upon completion, participant will be able to identify their own risks for BCC contamination when manufacturing non-sterile drug products.