Tag Archive | "guidance documents"

Q-IWG Releases Three More “Points to Consider” Documents

The ICH Quality Implementation Working Group has released its final three “Points to Consider” (PtC) documents, following the three it released last June.

As Group member Moheb Nasr pointed out last summer, the PtC documents “are not intended to be new guidelines.” Rather, they are intended to provide further clarity and facilitate regulation in regards to Q8, Q9, and Q10.

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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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J&J’s Fritschel: An Update on ICH Q11 (Now Available for Public Comment)

By Paul Thomas, Senior Editor

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Process Validation: Can We Now Get Back to Basics?

By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

It was around 2002. The message of change was in the breeze. At FDA’s advisory committee meetings, the language of science was used to examine and discuss Good Manufacturing Practices (GMPs), both in practice and in law. To support and enhance the milieu for change, and to prevent GMP’s from getting in the way of innovation, the “GMP’s for the 21st Century” program was initiated.

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Process Validation on Your Mind

We’re always interested in which articles and posts you’re reading on PharmaQbD.com. In looking back at our most-read items so far in 2011, it’s clear that FDA’s new process validation guidance is on your minds. Here are the top three items from January and February.

1. FDA Publishes Long-Awaited Process Validation Guidance

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FDA Publishes Long-Awaited Process Validation Guidance

After months of uncertainty and anticipation (see “Final Process Validation Guidance: Any Day Now?”), FDA has released “Process Validation: General Principles and Practices”.

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