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Posted On: 11/24/2004
IFPATMA Launches Supplier Certification Program
Editor's Note: The following is an open letter from Robert Zutkis of IFPAC:
In support of the FDA's PAT Guidance, we encourage all manufacturers of Process Analytical Technology (PAT) instrumentation, sensors, software, system integration packages, equipment, sub-assemblies, components, or PAT specific support products and services to join and participate in IFPATMA, the IFPAC Manufacturers Association.
This not-for-profit organization, recently renamed IFPATMA to align it more with the PAT initiative, aims to provide a platform of communication between the pharmaceutical and biotech industries, research institutions, academia, government agencies, and the manufacturers of PAT instrumentation, systems and technology.
As the FDA encourages pharmaceutical manufacturers to use the PAT framework to develop and implement new pharmaceutical manufacturing and technologies and continuous real time quality assurance, PAT vendors must be positioned, not only to support the FDA PAT initiative, but to help ensure its success. IFPATMA provides an essential link between industry, research institutions, academia, government agencies, and the manufacturers of PAT instrumentation, systems and technology.
IFPATMA represents suppliers, pharmaceutical industry users, academia, and regulatory agencies organized to promote the efficient utilization of PAT tools that meet the industry's and regulatory agency's fitness-for-use expectations. One if its critical goals is developing a vendor certification program based on the adoption and use of science based standards, generation of peer-reviewed; standardized PAT application platforms, as well as, providing educational opportunities that facilitate the use of PAT approaches to generate process understanding.
This certification program will help to streamline the process by which PAT suppliers and their technologies are evaluated by pharmaceutical firms. Because common goals are essential, the association is working hand-in-hand with the pharmaceutical industry to develop validation criteria. Board members of IFPATMA, include FDA representatives and key members of the pharmaceutical industry, including GlaxoSmithKline, Pfizer, Eli Lilly, and AstraZeneca, as well as key PAT suppliers including: Thermo Electron, Swagelok, Spectral Dimensions, Optimal, Kaiser Optical, Control Development, Bruker Optics, and Brimrose.
Other key focuses for IFPATMA include:
- Establishing a Quality Task Force -- The Association will prepare a White Paper on Vendor (Measurement) Quality System Certification. This will be used to more widely communicate what IFPATMA is attempting to accomplish, and at a fairly high level, what will be used to accomplish this goal.
- Educational Charter -- Education is critical to ensure appropriate use of PAT. The association is working with key organizations including ASTM Committee E55 on Pharmaceutical Application of Process Analytical Technology, as well as ISPE and other pharmaceutical associations.