By Emil Ciurczak, Contributing Editor

Sunday, January 22, 2012

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by Agnes Shanley

The GMP code requires that manufacturers run a “statistically significant” number of tests on product, and assumes that they maintain control over their processes. However, in practice, testing of batches is currently between 10-30 samples. As more drug manufacturers implement at-line, online or inline process analyzers, the number of tests run could potentially increase dramatically.

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by Agnes Shanley

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Modified-release drugs are inherently more challenging to develop and manufacture. It stands to reason that applying Quality by Design methodologies to MR products is more challenging as well—but even more important in order to understand and control their quality and efficacy.

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By Paul Thomas, Senior Editor

This month, the not-for-profit Regulatory Harmonization Institute was launched, with the mission of being a regulatory body to better represent the interests of emerging countries and “non-regulatory stakeholders.” (Read RHI’s press release here.) Founding members include BIO, the Generic Pharmaceutical Association (GPhA), and other notable global organizations, as well as representatives of AstraZeneca, Bausch & Lomb, and other major drug and device manufacturers. (See below for profiles of the organization’s leadership.)

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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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