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Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....

FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....

FDA Issues New BA/BE Draft Guidance

An FDA draft guidance for establishing bioavailability/bioequivalence (BA/BE) was released in late March and is intended to replace the existing 2003 BA/BE guidance. The guidance details the methods most suitable and accurate for the determination of BA/BE, as required by FDA. An expanded section is included on in vitro studies and their applicability for different formulations. […]

Interactions Between OGD’s Inactive Ingredients Database Working Group and IPEC on IID Content and Functionality Bearing Fruit

The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process....

Vetting of ICH Q3D Pre-Step 2 Impacts Final Draft; LVP and E&L Issues Could Warrant Further Public Comment

Large volume parenterals (LVPs) and extractables and leachables (E&Ls) from container closure systems were two issues on which the ICH Q3D Expert Working Group (EWG) requested input from stakeholders during the Step 2 drafting process without getting much feedback, and may warrant attention during the draft’s public comment phase that runs through December, EWG members are advising....

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

Biopharm Modeling and Continuous Manufacturing Will Help Drive Vertex’ Drug Development and QbD

Vertex is focusing on biopharmaceutics modeling and continuous manufacturing as potentially powerful tools for advancing its drug development and quality by design (QbD) program....

Virtual Innovator Vertex Pioneers New QbD Course with CMO Partners

A clear communication pathway with contract partners for escalating issues during and after development has been key to Vertex’ success in building state-of-the-art, quality-by-design (QbD) applications as a virtual company....

Operations/Quality & Management/Equipment Disconnects Undermine Industry’s Performance, Manufacturing Veteran Kranking Maintains at ISPE Meeting

The current lack of shop-floor experience in the management ranks together with a lack of training of operations personnel and their disconnection from quality responsibility are manifesting themselves in inefficient processes and recalls and warning letters, veteran manufacturing operations director Larry Kranking stressed at the ISPE Tampa meeting in late February....
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