Article preview from "The Gold Sheet" - July 1, 2009
Drug manufacturers and regulators are refining the quality-by-design approach to developing and reviewing the chemistry, manufacturing and controls section of new drug applications and they are learning how to take the new approach and apply it to operations at drug manufacturing facilities. Read more...
Article preview from "The Gold Sheet" - July 1, 2009
They are focusing much of their attention on the training and communications challenges in their efforts to advance quality by design from concept to reality. To a large degree, this means bridging the gap in industry between development and manufacturing and in FDA between reviewers and investigators.
The gradual realization of the new drug manufacturing quality paradigm that is under way became clear June 1-2 during the PQLI session of the ISPE Washington conference.
ISPE's PQLI initiative is playing a key role in addressing practical challenges to implementation of the QbD concepts that the International Conference on Harmonization set forth in its Q8, Q9, Q10 and planned Q11 guidelines.
Pfizer's Roger Nosal told the meeting how PQLI aims to help drug makers implement the ICH guidelines. The group will complement the guidelines with practical case studies, training materials, technical documents and workshops. In areas where further discussion is needed, the group will prepare technical papers, conference sessions and webcasts where industry and regulators can interact.
There were breakout sessions at the meeting organized by PQLI task teams on criticality, design space and control strategy. PQLI also has teams for legacy products and illustrative examples, and there is interest in exploring the application of QbD to biotechnology products and pharmaceutical excipients.
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