Why Burkholderia cepacia complex is treated as a special-case objectionable organism, and what USP <60> requires for non-sterile aqueous products.
This course covers why Burkholderia cepacia complex is treated as a special-case objectionable organism, USP <60> testing requirements and which product categories they apply to, the regulatory history and recall pattern that led to USP <60>'s introduction, and how BCC contamination typically enters a non-sterile aqueous manufacturing process.
Burkholderia cepacia complex organisms can survive and even thrive in preservative systems that would kill most other objectionable organisms, which is exactly why a string of recalls in aqueous non-sterile products led to a dedicated USP chapter. Standard USP <62> testing alone is not enough for at-risk product categories.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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