Prior to purchasing and validating a RMM, there are a number of due diligence activities that should be undertaken.
These may include a thorough understanding of the scientific needs of the RMM, the technical benefits the RMM possesses as compared with the existing method, regulatory impact, economic advantages, and the role of the RMM supplier in terms of providing support during the initial assessment, validation exercises, and most importantly, after the system has been placed in service for routine use.
When companies evaluate rapid methods for use in their microbial quality control testing, one area that can often cause confusion is the validation requirements of the various methods.
For example, methods that are growth-based have different validation requirements to methods that would be considered alternative, and within the alternative methods there are differences based on the scientific method employed.
State-of-the-art presentations from authority speakers, as well as industrial and academic experts in the field of microbiological detection and identification and mycoplasmology with particular focus on the current methodologies their implementation and validation will provide an in-depth overview.
The scientific progress in the field of cellular and molecular biotechnology led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs).
As author over a hundred technical publications and numerous presentations within the area of rapid microbial detection, editor of PDA’s reference book of Rapid Microbiological strategies, and the owner of the most complete website dedicated to rapid microbial detection) we are happy to share a series of his articles that previously appeared in European Pharmaceutical Review.
EXPERTISE AND CURRICULUM VITAE (CV) When microbiology was in its early stages of development, scientists used liquid media for the cultivation of microorganisms.
Whatever method is selected, it must be validated before moving into routine use.
For people who were in want of a method to segregate individual varieties of organisms or pure cultures, using liquid media had many big disadvantages.
This was the case for Dr Koch, who, in 1881, was determined to search out an alternate methodology for his experiments.
This new approach is encouraged by the FDA and the EMEA (European Medicines Agency). Internationally recognized microbiologist and currently President of Microbiology Consultants, LLC.
He is known for his knowledge on Rapid methods and providing clear scientific, quality solutions for the (pharmaceutical) industry. Miller has over twenty four years of experience – R&D projects, quality of production programs, consulting and business development- in leadership roles at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb, and Pharmaceutical Systems, Inc.
Among other stakeholders, the validation process requires involvement of quality assurance personnel and external regulatory agencies if a license change is required.