Quality Systems and Risk Management Approaches for Networked Drug Development David A. Moyer VP, Regulatory Compliance Programs Fulcrum Pharma Developments, Inc. PDA SciTech Summit Orlando, Florida March 10, 2004. Tailored Networked Team. Advisory . Boards. Regulatory/QA. Project . CMC.
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Quality Systems and Risk Management Approaches for Networked Drug DevelopmentDavid A. MoyerVP, Regulatory Compliance ProgramsFulcrum Pharma Developments, Inc.PDA SciTech SummitOrlando, FloridaMarch 10, 2004
Standard Operating Procedures
Message, Issue, Response, Support
“The CGMP regulations for drugs have not been updated in 25 years . . . Continuous quality improvement in manufacturing hasn’t been the subject of as much attention in the pharmaceutical industry . . . FDA’s broad-based program is working on developing new guidance based on the latest science of risk management and quality assurance.”
Quotes by Mark B. McClellan, M.D., Ph.D.
FDA’s Strategic Action Plan – August 2003
The goal of PAT is to understand and control the manufacturing process, i.e., quality cannot be tested into products; it should be built-in or should be by design.
Fantastic solution to promote innovation given appropriate resources, but what risk management/quality improvement options are available to “little pharma” and companies with existing products?
Hazard Analysis at Critical Control Points (HACCP)
An Old Tool with a New Purpose
"If you can't describe what you are doing as a process, you don't know what you're doing"
– W. Edwards Deming