The monitoring of microbial contamination is one of the critical procedures in the control of the manufacturing process and quality of the finish products in pharmaceutical industry. Many compendial methods used today offer low probability of detection except for gross contaminations. Rapid microbiological methods start to gain track in the industry, due to their increased adoption and validation, but also because of the clarification from the regulators. There are several well-developed rapid microbiological methods now becoming available that may have useful applications in pharmaceutical and medical devices.
The advent of the new therapies like the Advanced Therapy Medicinal Products, Cell and Gene Therapy that makes products with a short shelf life or products prepared for immediate use sorts the needs for rapid microbiological methods that allowed the minimization and mitigation of the risk of contamination.
The pharmacopeias have evolved as well to provide guidance on the selection, evaluation, validation and proper implementation of rapid microbiological methods as alternatives to compendial methods.
This training will be focused on the understanding of the classical methods described in the pharmacopeia and the currently available rapid microbiological method technologies, the regulatory requirements, the validation strategies and implementation plans.