Re: ISPE and FDA Co-sponsor One-Day Forums on New PAT Guidance
(TAMPA, FL) – ISPE and the FDA are co-sponsoring a global series of one-day forums for Life Sciences professionals based on the FDA’s new guidance for Process Analytical Technology (PAT). The document, entitled Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, provides a risk-based, regulatory context in which pharmaceutical and biopharmaceutical companies can improve efficiency and quality assurance through an improved focus on design and control.
“Cooperating with ISPE in these forums affords us the unique opportunity of reaching a global audience to discuss the PAT framework, and address questions regarding the Agency’s regulatory approach to PAT. More importantly, discussing examples of industrial implementation and experiences with the Agency’s team approach to review and inspection will demonstrate the practicality of the PAT framework,” said Chris Watts, Staff Fellow and member of the PAT Team in the Office of Pharmaceutical Science at the FDA’s Center for Drug Evaluation and Research.
The PAT Forums represent innovation on another level, as an unprecedented partnership of the FDA and ISPE to provide training for next-generation pharmaceuticals manufacturing. “The release of the PAT guidance is an excellent example of how worldwide regulatory agencies can and must encourage innovation in manufacturing processes, with the ultimate goal of higher-quality, safer products,” said Bob Best, President and CEO of ISPE. “Together with the FDA, ISPE is committed to helping move our industry into the next generation by providing information exchange and education to help companies understand and apply the concepts in the guidance. These concepts should enable fully flexible manufacturing systems that, within regulation and considering risk, encourage the best engineering and scientific principles available to improve business.”
Slated for four different international cities, the upcoming PAT Forums will provide an overview to the tools and principles outlined in the new FDA guidance, and describe how these concepts can help organizations meet regulatory requirements for designing, controlling and optimizing the development, manufacturing and quality assurance processes. For additional information or to register for a PAT Forum, visit
or contact the ISPE Education Department by tel: 1-813/960-2105 or e-mail: customerservice@ispe.org. A limited number of press passes are available, contact Marcela Leon by tel: (813) 960-2105 x 248 or e-mail: melon@ispe.org for more information.
PAT Forum Schedule
Arlington, Virginia
16 November, 2004
Tokyo, Japan
8 December, 2004
Brussels, Belgium
22 February, 2005
Mumbai, India
25 February, 2005
About PAT
As defined in the FDA guidance, PAT is “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” PAT represents the wave of the future for the pharmaceutical industry—a formula for encouraging innovation and efficiency in product and process development, process analysis, and process control. Based on the idea that quality should be built or designed into new products, PAT incorporates the most up-to-date concepts of risk management and quality assessment systems into pharmaceutical manufacturing.
The new guidance is a science-based, risk-based framework that supports innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. To read more about the guidance, visit the FDA Web site at www.fda.gov/cder/OPS/PAT.htm.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 20,000 Life Science professionals in 80 countries. Founded in 1980, ISPE aims to enhance industry practices by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. ISPE Headquarters are based in Tampa, Florida with a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information. ■
New PAT Guidance
Date: November 5, 2004
Re: ISPE and FDA Co-sponsor One-Day Forums on New PAT Guidance
(TAMPA, FL) – ISPE and the FDA are co-sponsoring a global series of one-day forums for Life Sciences professionals based on the FDA’s new guidance for Process Analytical Technology (PAT). The document, entitled Guidance for Industry: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, provides a risk-based, regulatory context in which pharmaceutical and biopharmaceutical companies can improve efficiency and quality assurance through an improved focus on design and control.
“Cooperating with ISPE in these forums affords us the unique opportunity of reaching a global audience to discuss the PAT framework, and address questions regarding the Agency’s regulatory approach to PAT. More importantly, discussing examples of industrial implementation and experiences with the Agency’s team approach to review and inspection will demonstrate the practicality of the PAT framework,” said Chris Watts, Staff Fellow and member of the PAT Team in the Office of Pharmaceutical Science at the FDA’s Center for Drug Evaluation and Research.
The PAT Forums represent innovation on another level, as an unprecedented partnership of the FDA and ISPE to provide training for next-generation pharmaceuticals manufacturing. “The release of the PAT guidance is an excellent example of how worldwide regulatory agencies can and must encourage innovation in manufacturing processes, with the ultimate goal of higher-quality, safer products,” said Bob Best, President and CEO of ISPE. “Together with the FDA, ISPE is committed to helping move our industry into the next generation by providing information exchange and education to help companies understand and apply the concepts in the guidance. These concepts should enable fully flexible manufacturing systems that, within regulation and considering risk, encourage the best engineering and scientific principles available to improve business.”
Slated for four different international cities, the upcoming PAT Forums will provide an overview to the tools and principles outlined in the new FDA guidance, and describe how these concepts can help organizations meet regulatory requirements for designing, controlling and optimizing the development, manufacturing and quality assurance processes. For additional information or to register for a PAT Forum, visit
http://www.ispe.org/gotoFDA-ISPEPATforum,
or contact the ISPE Education Department by tel: 1-813/960-2105 or e-mail: customerservice@ispe.org. A limited number of press passes are available, contact Marcela Leon by tel: (813) 960-2105 x 248 or e-mail: melon@ispe.org for more information.
PAT Forum Schedule
Arlington, Virginia
16 November, 2004
Tokyo, Japan
8 December, 2004
Brussels, Belgium
22 February, 2005
Mumbai, India
25 February, 2005
About PAT
As defined in the FDA guidance, PAT is “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” PAT represents the wave of the future for the pharmaceutical industry—a formula for encouraging innovation and efficiency in product and process development, process analysis, and process control. Based on the idea that quality should be built or designed into new products, PAT incorporates the most up-to-date concepts of risk management and quality assessment systems into pharmaceutical manufacturing.
The new guidance is a science-based, risk-based framework that supports innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. To read more about the guidance, visit the FDA Web site at www.fda.gov/cder/OPS/PAT.htm.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 20,000 Life Science professionals in 80 countries. Founded in 1980, ISPE aims to enhance industry practices by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. ISPE Headquarters are based in Tampa, Florida with a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information. ■