The following is a chronological listing of IPQ stories since 2010 that have covered the pressing issues around post-approval changes and what is needed in conjunction with advancements in risk and knowledge management to make quality regulatory processes across the product lifecycle more cohesive, efficient, process improvement and supply friendly, and internationally harmonized. 2010 ● […]
Drawing attention in the January issue are: ● how the research, technologies and partnerships that have been gelling in recent years made possible the rapid development of a coronavirus vaccine in 2020 ● how USP has intensified its focus on supply chain vulnerabilities and vaccine/treatment development to help support the pandemic response, and ● FDA’s ongoing progress in improving the usefulness and user-friendliness of its inactive ingredient database (IID).
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In mid-May, EDQM published a draft of its first finished product monograph, covering sitagliptin phosphate tablets, for comment. The monograph is available in the online forum Pharmeuropa. EDQM notes that “finished product monographs will be elaborated according to the same general principles as for other monographs in the Ph. Eur. to ensure the same high […]
As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.] The attention the stories drew is not surprising as they delve into four key current focal points in the CMC/GMP regulatory arena: ● data integrity ● contract relationships ● quality metrics, and ● process validation.
As a retrospective on the past year, IPQ is providing a compilation of the four stories that generated the largest readership. [Available in full to non-subscribers as well as subscribers.]
To kick off the New Year, IPQ is providing a compilation of the ten stories that generated the largest readership in 2012.