IPQ

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IPQ

 •  December 29, 2017

Provided below are: ● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3) 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... You must be a paid...

IPQ

 •  December 14, 2017

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. GDUFA II calls for surveillance inspections to be classified...

IPQ

 •  December 13, 2017

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...

IPQ

 •  November 26, 2017

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). The new...

IPQ

 •  November 13, 2017

Provided below are: ● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3) 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...

IPQ

 •  October 23, 2017

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...

IPQ

 •  October 13, 2017

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. In a keynote presentation at the ISPE/FDA/PQRI...

IPQ

 •  September 9, 2017

Provided below are: ● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3) 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...

IPQ

 •  August 24, 2017

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. The ICH Q3D...

IPQ

 •  August 7, 2017

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. Having shown the effectiveness of the mass spectrometry-based MAM in...