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IPQ Monthly Update – October / November 2017 in Review

The first two stories in this issue explore the drug GMP compliance concerns that are most pressing on the FDA agenda as 2018 approaches. The third story returns to the intensifying global dialogue on the stresses industry and regulators are feeling as they wrestle with how to advance drug/biologic/device combination products in the context of regulatory structures and processes not very well adapted to handle them.

Faster Inspection Follow-Up, Global Workload, Draw CDER Compliance Office Attention as 2018 Approaches

The impact of FDA’s foreshortened inspection classification timelines, as prescribed by the second installment of the Generic Drug User Fee Act (GDUFA II), will include placing additional weight on the quality of the 15-day inspection responses, agency compliance officials are noting. 

Contracting Relationships and Quality Agreements Are High on FDA’s Inspection Radar Screen

The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) is making clear in its public presentations, compliance actions, and guidance to industry that the relationship between contract manufacturers and product owners – and the quality agreements they have in place to facilitate this relationship – will be a key focal […]

Europe is Assessing Challenges of Implementing Combination Product Regulatory Changes; Attention on CPs Increasing Globally

The stress on the resources and expertise of the European notified bodies in taking on the assessment of the device component of higher-risk drug/device combination products is among the significant challenges the EU faces as it enters the implementation phase of its new medical device and in vitro diagnostic regulations (MDR/IVDR).

IPQ Monthly Update – August / September 2017 in Review

The three stories in this issue provide insights from industry and agency thought leaders on how the pharma imperatives of innovation, acceleration and regulatory harmonization are putting pressure on the existing regulatory processes and quality systems and what industry and agencies such as FDA are doing to try to evolve them.

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.
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Front page Nov.Dec. 2015Click here for the November/December 2015 Monthly Update

 

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