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Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods

 
• By Joanne S. Eglovitch

EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.  

Portable Raman Spectrometer - Image

More than a decade after the pharmaceutical industry and leading regulatory authorities adopted the quality-by-design approach to pharmaceutical development, it looks like QbD concepts are finally going to extend to analytical methods. ICH is planning to propose guidance in early 2020 that it hopes to finalize a year later. Meanwhile, a European industry group has provided additional guidance to help industry prepare for the emerging lifecycle management approach to analytical procedures.

A paper from the European Federation of Pharmaceutical Industries and Associations explains how manufacturers can implement some of the enhanced approaches to analytical method validation in anticipation of the International Council of Harmonization’s upcoming Q14 guideline and an associated revision of its Q2(R2) guideline

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

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