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The News in Depth

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....

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....

Amgen “Analytics of the Future” Initiative Develops MS-based “Multi-Attribute Methodology” to Streamline Biotech Development and QC Testing

Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design....

Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program

Detailed, transparent technical discussions with suppliers, long-term supplier relationships, and a wide-ranging event monitoring system are three prongs in Amgen’s intensive effort to avoid supply disruptions and improve quality assurance....

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....
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