2019 USP <60> Microbiological Examination of Nonsterile Products Tests for B Cepacia Complex
: 23 Jul 2019
Sector: Clinical, Cosmetic/Personal Care, Pharmaceutical, Water
Type: Training, Webinar, Seminar
Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this Complex in a drug manufacturing operation is an important public health goal.
The new draft General Chapter USP<60> is designed as an extension of USP<61>/<62> General Chapters and to increase the probability of detection of the BCC over the current methods described in USP<62>. While this Chapter will not provide for speciation of the BCC, it will provide methodology to provide a presumptive identification based upon verification/qualification.
The objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the draft General Chapter USP<60>, media that is proposed, genotypic consideration as well as recalls, FDA 483s and Warning Letters. Please plan to bring an interdisciplinary team to this training session to explore how knowledge regarding this contaminant and its Complex may assist you in your facilities and minimize it as an Objectionable microorganism/group.
- A review of the pertinent history of B. cepacia/Complex.
- Extensive review of the process involved in the isolation and identification of B. cepacia/Complex.
- Explore the “new” recommended medium for propagation of this microorganism and its Complex.
- Learn why USP<60> does not provide a sufficient identification (genus/species).
- Use of B. cepacia within USP<1111> as a potential monograph addition.
- Experience what Companies have encountered with Recalls, Form FDA 483s and Warning Letter examples.
- Case studies of Warning Letters with B. cepacia/Complex.
- Low Endotoxin Recovery: Assessment of PDA TR82 & Demasking of Endotox