Bethesda, Md., May 15, 2017 – The Parenteral Drug Association (PDA) today announced the publication of Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems,which provides a practical guide on how to manage quality risks throughout the manufacturing system lifecycle. Technical Report 54-5 includes two case studies illustrative of the concepts developed in the main body of the document. In June, PDA is sponsoring the 2017 Quality Risk Management for Manufacturing Systems Workshop,which will cover the concepts elucidated in Technical 54-5, at the Hyatt Centric Chicago Magnificent Mile, Chicago, Ill., June 19-20.
“Managing the inherent risks common to all manufacturing processes is an important element in protecting the quality of drug products and public health,” said PDA President & CEO Richard Johnson. “Left unmanaged, the goals of high-quality and safe drugs is jeopardized.”
The interactive workshop will help participants learn about emerging trends in quality risk management. A mix of industry and regulatory representatives will be speaking and leading discussion groups, including:
- Jason F. Chancey, Regulatory Officer, CDER, FDA
- Carrie Ann Plucinski, Consumer Safety Officer, CDER, FDA
- Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority
The quality risk management technical report and workshop is part of PDA’s umbrella Manufacturing Science and Operations ProgramSM (MSOPSM), which is bringing together experts throughout the industry to:
- Highlight the ongoing focus PDA has on pharmaceutical and biopharmaceutical manufacturing
- Strengthen and build practical solutions by filling known gaps in current manufacturing science as well as gaps that will become apparent based on ongoing developments and analyses
- Identify and encourage use of new manufacturing technology and methods