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IPEC Seeks to Narrow Excipient Maker/User Communication Gap on Visible Particles

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is spearheading an effort to strengthen the communication pathway between excipient makers and users about the significance of benign visible particles in excipients....

FDA’s New Office of Program and Regulatory Operations Will Assume Pivotal Role in CMC Review

FDA’s Office of Program and Regulatory Operations (OPRO) – part of the new Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research (CDER) – will be responsible for co-leading and facilitating the review of the quality portions of new and abbreviated new drug applications (NDAs/ANDAs)....

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....

IPQ Monthly Update, October 2014

In focus are: ● the structure/function changes FDA is making to help drive a new pharmaceutical quality regulatory paradigm with closer center/field alignment ● the role that the new Office of Pharmaceutical Quality will play in steering the various significant initiatives that are now in motion, and ● the implementation challenges presented by the new ICH guidelines on elemental impurities (ICH Q3D) and mutagenic impurities (ICH M7), respectively....

Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels

Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....

CDER’s Office of Pharmaceutical Quality Will Become Functional in January Following Commissioner’s Call for Commodity-Oriented Center/Field Alignment

The initiatives underway at FDA’s Center for Drug Evaluation and Research (CDER) that its new Office of Pharmaceutical Quality (OPQ) will help drive include expertise-based team reviews, closer review/inspection alignment, an auditable quality management system (QMS), a comprehensive pharmaceutical quality IT platform, and new preapproval and surveillance inspection approaches....

Team-Based Quality Assessment Approach Among Key Changes Underway as CDER’s Office of Pharmaceutical Quality Comes to Life

FDA’s Center for Drug Evaluation and Research (CDER) is finding that its new “team-based integrated quality assessment” model makes the review process more efficient and effective, and the model is winning the praise of team members involved....

ICH Q3D Could Provide Model for More Inclusive ICH Process; Focus Continues on Q3D Implementation Challenges, Including Risk Assessments

The development and implementation of the ICH Q3D guideline on elemental impurities could provide a model for a more inclusive ICH process....

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

New CMC Submission Approach Needed to Foster Transparency and Continuous Improvement, PhRMA Team Says; Embedding Control Strategy as Regulatory Commitment in QOS Proposed

A working group of prominent CMC experts across the member companies of the Pharmaceutical Research and Manufacturers of America (PhRMA) has formulated a proposal for a more performance and risk-based regulatory approach to CMC submissions that would better accommodate post-approval manufacturing and control improvements....
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