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The News in Depth

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....

IPQ Monthly Update, April/May 2015

IPQ’s coverage during April and May was heavily focused on how the GMP/quality system thought processes in the pharmaceutical regulatory arena are advancing, and the April and May issues have been combined to bring the stories under one roof. Included in the April/May Monthly Update are stories covering: ● CDER Director Woodcock on the philosophy behind FDA’s “quality revolution” – why fear is antithetical to its goals and why measurement is key ● a Deming Institute expert on where pharma is in applying Deming’s quality philosophy ● a compliance official on what FDA’s foreign inspection findings indicate about pharma’s current risk modeling overseas ● the impact of the new risk-oriented ANSI NSF-IPEC 363 excipient GMP standard on excipient suppliers and drug manufacturers, and ● Sanofi’s effort to coordinate the lifecycle management of its automation systems to head off manufacturing breakdowns…

Sanofi is Coordinating the Lifecycle Management of its Automation Systems to Head Off Manufacturing Breakdowns

Sanofi is focusing more attention on coordinating the lifecycle management of its automation systems to head off the major threats to the continuity of manufacturing operations that ensue from not having a well thought-out planning process in place....

Pharma May be Missing 80% of the Power of Deming’s Methods, Deming Institute Expert Maintains at PDA/FDA Q10 Workshop

Deming Institute Advisory Board Chairman Kelly Allen maintained at a PDA/FDA Pharmaceutical Quality System (ICH Q10) Workshop on Quality Risk Management that the pharmaceutical industry has, in general, been missing 80% of the power of Deming’s management methods, which involve understanding: ● the organization as a system ● variation ● the theory of knowledge, and ● human psychology....

High Foreign Inspection Failure Rate Indicates Need for Better Pharma Risk Modeling and Supplier Oversight Abroad, FDA Compliance Official Stresses

The current high FDA foreign inspection failure rate points to the need for the pharmaceutical industry to develop better risk models and intensify supplier oversight abroad, a senior official at the Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is stressing....

Implementing the ANSI NSF-IPEC 363 Standard on Excipient GMPs Will Help Ensure Compliance with FDASIA, FMD and EU’s New Excipient Risk Assessment Guideline

Implementation of the ANSI NSF-IPEC 363 standard on GMPs for excipients by pharma and excipient manufacturers will help ensure that they are compliant with the supply chain mandates of the FDA Safety and Innovation Act (FDASIA), the EU Falsified Medicines Directive (FMD), and the newly-completed EU excipient risk assessment guideline....

Fear-based Relationships Antithetical to Progressing Quality Systems, While Measurement is Key, CDER’s Woodcock Stresses at ISPE Metrics Forum

The principle that fear-based relationships are antithetical to progressing quality systems is pivotal as FDA reshapes its quality regulatory approach, CDER Director Janet Woodcock is stressing....

IPQ Monthly Update, March 2015

During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality....

FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies

FDA is advising companies developing cell and gene therapy (CGT) products to focus on improving the characterization of products, control of the manufacturing process, and design of the related potency assays....
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March front page picClick here for the March 2015 Monthly Update

 

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