Microbial Quality Control in Manufacturing of Medicinal Products

DATE:  September 29, 2020

TIME:   8:00am PT, 11:00am ET

There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized products are also scrutinized by the regulators. These issues span from manufacturing, where systems are inadequate to control microbial contamination to laboratory operations where media, test method validations and testing is non-optimal. These 483 observations relate to procedural deficiencies, laboratory operations, aseptic manufacturing, environmental monitoring and cleaning and disinfection. These repeat observations point towards a lack of understanding of microbial contamination control as well as lack of a quality centric culture, business taking priority over compliance and patient safety, lack of knowledge and expertise which leads to misidentifying or ignoring risks.

 

Learning Objectives