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Microbial control of non-sterile drug products is essential as the presence of objectionable microcontamination in non-sterile drug products poses a risk to patient safety and product stability. Recent incidents associated with Burkholderia cepacia complex (BCC) contamination in non-sterile aqueous products emphasizes the importance of a robust design and control program to prevent non-sterile drug product manufacturing risks. An effective risk-based approach will help to understand and mitigate potential microbial hazards in manufacturing and evaluate their potential impact on the finished product quality.
This session will focus on the quality risk management of microbial risks of non-sterile products by taking into consideration, among other things, the dosage form characteristics, hygienic design and maintenance of process equipment, including the water system, cleaning and sanitization program, and the type of manufacturing process as these may impact the contamination risk level.
.jpg "Pahala Simamora, PhD photo")
Pahala Simamora, PhD
Division Director, OPQ, CDER
U.S. FDA
SIlver Spring, Maryland, United States
Andrew Dick, MS
Vice President Global Hygiene and Microbiology
KDC/One
East Windsor, New Jersey, United States
.jpg "Sandra A. Boyd photo")
Sandra A. Boyd
Drug National Expert
U.S. FDA
Milwaukee, Wisconsin, United States
Erika A. Pfeiler, PhD
Supervisory Microbiologist, CDER
U.S. FDA
Silver Spring, Maryland, United States