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.
- Procedures related to microbiological quality control
- Inadequate laboratory controls
- Investigations not adequate
- Environmental monitoring system deficiencies
- Equipment and utensils are not maintained or cleaned at appropriate intervals
- Deficient aseptic processing
- Cleaning and disinfection program deficiencies
Highlight that microbial contamination risks are tangible, and it is crucial to understand these risks at every stage of manufacturing of medicinal products.
Without an adequate knowledge base and the use of science in microbial contamination risk assessments, these issues will persist.
Learn where microbial control fails from FDA 483 observations and case studies presented in this session.
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