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The News in Depth

FDA’s Office of Pharmaceutical Quality Advances Review/Inspection Integration

FDA has put in place an umbrella “Concept of Operations” (ConOps) intended to support the Office of Pharmaceutical Quality (OPQ) in its efforts to ensure consistency, efficiency, and transparency in facility evaluations, inspections, and regulatory decision-making for marketing applications and create a more cohesive review/inspection process.

Quality System Transformation Needed for Next-Gen Product Acceleration, Johnson & Johnson’s Sallans Tells ISPE/FDA/PQRI Conference

A transformation in quality systems is needed to liberate the power of information, digital, manufacturing and analytical technologies and accelerate the next generation of medical products reaching the patient, Johnson & Johnson Chief Quality Officer Francois Sallans affirmed in his keynote address at the opening of the ISPE/FDA/PQRI Quality Manufacturing Conference in June.

Tension Between Quality Regulatory Paradigm and Pharma’s Innovation, Acceleration and Harmonization Imperatives in Spotlight

Pfizer VP and Global CMC Head Roger Nosal is among prominent pharma thought leaders who are articulating the growing tension between the existing quality regulatory paradigm and the pharma imperatives of innovation, development/review acceleration, continuous improvement and regulatory harmonization.

IPQ Monthly Update – June / July 2017 in Review

The issue opens with a review of the key priorities of the European Pharmacopeia and its ongoing initiatives to address them. Included are the pharmacopeia’s efforts in ICH Q3D implementation and in the biotherapeutics and co-processed excipient arenas. The second story focuses on MS-based multi-attribute methodology (MAM) and the increasing attention it is drawing in the industry/regulator dialogue. The attention reflects the potential MAM has already shown in biomolecule characterization, design and development, and the challenges involved in realizing its full potential in streamlining QC release and supporting advanced/continuous processing.

European Pharmacopoeia Has Turned Up the Heat on ICH Q3D Implementation and Biotherapeutics

The July 2017 publishing by the European Pharmacopoeia (Ph. Eur.) of revisions to its general chapter, method, and monograph sections is the latest development in the effort by the pharmacopeia to align its coverage of elemental impurities (EI) with the implementation of the International Conference on Harmonization (ICH) Q3D guideline.

Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC

Biopharmaceutical manufacturers are seeking to expedite the process of taking multi-attribute methodology (MAM) from the development to the quality control (QC) arena and are working with analytics providers and government agencies to help address the challenges involved.

IPQ Monthly Update – April / May 2017 in Review

The issue opens with an in-depth analysis of the array of significant new developments that have occurred in 2017 in FDA’s push to strengthen its regulatory process for drug/device combination products. The focus than shifts to the experience and learnings of the first two companies to cross the CM approval finish line – Vertex and J&J’s Janssen. Moving to developments abroad, the final story centers around the impact on global excipient and pharma filings and product compliance of new requirements in China for the “bundling” of the excipient approval process with drug dossiers.

Janssen Highlights Value of Academic Collaboration in Move to Continuous Manufacturing

Janssen scientists involved in the successful transition from batch to continuous manufacturing (CM) for its anti-HIV product Prezista are forthright in their recognition of the role played by academia – especially Rutgers University – in addressing the technical and regulatory challenges.

Global Excipient and Drug Manufacturers Weigh Implications of China’s New Excipient Dossier and “Bundling Review” Requirements

Global excipient and pharmaceutical manufacturers are weighing the complexities and consequences of the new “bundling review” requirement put in place by the China Food and Drug Administration (CFDA) in August 2016, which calls for excipient dossiers to be received, reviewed and approved as part of new drug applications.

New and Generic Drug User Fees, 21st Century Cures Act, Fuel FDA Regulatory Process and Culture Changes for Combination Products

The process of reauthorizing user fees for new and generic drug products has afforded the Center for Drug Evaluation and Research (CDER) the opportunity to work cooperatively with industry to drive significant cultural and process enhancements in its regulation of drug/biologic/device combination products.
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