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The News in Depth

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....

Novartis Exploring Boundaries of Biotech Manufacturing and Control to Make Cell and Gene Therapy Commercialization a Reality

Novartis is among the major global pharmaceutical companies that are taking a hard look at how the advancements in biotech manufacturing and control technology and systems can be adapted to help make cell and gene therapy (CGT) commercialization a reality....

Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel

Putting in place a QC-friendly potency assay to support commercialization of cell and gene therapy (CGT) products will require an iterative process that needs to be thought out early in development with regulator input, experts involved are advising....

Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion

Regulators around the world have been taking the opportunity at recent international forums to benchmark on their respective efforts to create a viable framework for regulating the manufacturing and control of cell/gene/tissue therapies and to consider harmonization possibilities....
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March front page picClick here for the March 2015 Monthly Update

 

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