Tag Archive | "ICH Q10"

The Continually Improving Pharma Quality System

By Erica Brooks and Yasmeen Muhammad, Compliance Implementation Services

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Nasr in Chicago: An ICH Working Group Progress Report

By Paul Thomas, Senior Editor

This week at DIA 2011, at Chicago’s McCormick Place, Moheb Nasr, director of FDA CDER’s Office of New Drug Quality Assessment (ONDQA) and a key member of the ICH Quality Implementation Working Group, provided an overview of the working group’s recent activities and future goals. The Q-IWG has spearheaded the development and implementation of ICH Q8, Q9, and Q10, and Nasr stated that it has made great progress towards achieving its goals, but outlined current and future challenges as well.

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Sage Quality Management Advice? Only the Shadow Knows

A new blog started up this summer devoted to issues of pharma Quality Assurance, with a slant toward current, progressive practices as espoused in ICH Q10 and other documents. The QA Pharm, which posts every week or so, is a welcome voice in the ongoing discussions of what constitute best practices in pharmaceutical Quality.

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Q8, Q9, Q10: Questions to Contemplate

FDA has made available a final version of its “Q8, Q9, and Q10: Questions and Answers” document, an updated version of previous Q&A documents that had been released by the ICH Quality Implementation Working Group.

The guidance is helpful for QbD professionals and trivia buffs alike. Some of the questions that are addressed:

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You Just Need a Spreadsheet: Dispelling the Myths of FMEA

Toronto’s Dyadem provides Quality Risk Management (QRM) solutions and helps biotech and pharma companies establish a foundation for an ICH Q10 Pharmaceutical Quality System. We recently spoke with CEO Kevin North about a critical aspect of risk management, FMEA.

PQbD: What is FMEA’s role in a Quality by Design context? What function does it perform?

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