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IPQ Monthly Update — November/December 2015 in Review

With the ICH Q12 initiative operating as a catalyst, the dialogue has been intensifying on what is needed to make quality regulatory processes across the product lifecycle more coherent, efficient, process improvement and product supply friendly, and internationally harmonized. This IPQ Monthly Update departs from the usual format to provide a series of stories exploring the various dimensions of the lifecycle management regulatory challenge and the international effort to better address it....

IPQ Monthly Update — Nov. Dec. 2015

The Monthly Update covering November and December 2015 is now available...

IPQ Monthly Update — September 2015

The IPQ Monthly Update covering September 2015 is now available.

IPQ Monthly Update — July/August 2015 in Review

IPQ's Monthly Update for July/August 2015 is now available.

IPQ Monthly Update, July/August 2015 in Review

Dominating IPQ’s coverage during July and August were the ongoing developments in FDA’s metrics effort and the industry initiatives it is driving. In focus in this issue are: ● FDA’s new draft guidance and where the agency is looking for input from industry, in particular, in refining it, and ● ISPE’s substantial pilot effort to benchmark on current metrics practices and help make the FDA program more viable and meaningful. A third story explores the increasing significance of pharma’s relationship with excipient suppliers from the vantage point of a senior BMS manufacturing executive, and the related IPEC-Americas/IQ Consortium push for a novel excipient regulatory pathway.

IPQ Monthly Update — June 2015

The IPQ Monthly Update for June 2015 is now available.

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential

The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....
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