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Reshaping pharmaceutical quality
Date:6/2/2008

patient and business requirements, as well as showing the linkage from critical quality attributes. The Legacy Products Team has started work and will produce a paper later in 2008 in JPI.

"The task teams are to be congratulated for their technical publications in the Journal of Pharmaceutical Innovation which embrace input from interactive global workshops that included participation from both industry and regulators," said Moheb M. Nasr, Ph.D., Director, Office of New Drug Quality Assessment (CDER, FDA). "These papers, and the PQLI initiative, are important 'next steps' to facilitate the implementation of QbD and to answer the tangible challenges."

Jacques Morenas (AFSSAPS) and current chairman of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) said, "EU regulators are ready to work with ISPE on the future role of the EU Qualified Person, taking into account how critical it is. Work is already in progress as we can see from efforts made in conjunction with the Processed Analytical Technology (PAT) Team at the European Medicines Agency (EMEA) level and we will be happy to continue."


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Contact: Joan Robinson
joan.robinson@springer.com
49-622-148-78130
Springer
Source:Eurekalert

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