The validation, approval, and implementation of rapid and alternative microbiological methods has been steadily increasing within the pharmaceutical, biopharmaceutical, compounding pharmacy, and advanced therapy medicinal products (ATMP, gene and cell therapy) industries. Novel drug products and innovative manufacturing processes now require modern strategies for demonstrating microbiological control.
The 2019 PDA Rapid Microbiological Methods Workshop will provide attendees with an overview of the current landscape for rapid method validation strategies, implementation opportunities, and global regulatory approval processes. Presentations by subject matter experts and global regulators will focus on real-world practices for rapid and alternative microbiology testing of in-process samples and sterile and nonsterile finished product.
Major topics to be covered will include:
- Regulatory expectations for validation and implementation
- The impact of the revised Annex 1 on the use of rapid methods
- How to overcome roadblocks and perceived issues related to the implementation of alternative microbiology assays and instrumentation
- Recent case studies by industry end users on validation, regulatory submissions, and implementation
- The detection of microorganisms relevant to manufacturing processes, environmental monitoring, and facility control, including Mycoplasma
- Current status of compendial chapter in support of rapid methods
- New paradigms necessary for the acceptance of technologies not based on the colony-forming unit
This Workshop will present practical approaches to rapid microbiology testing that participants can use in daily work, laboratory, and manufacturing operations.