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GMP News

New USP Requirements for Asbestos Testing in Pharmaceutical Talc

Since 1 June 2026, the revised USP Talc monograph has been official. Both X-ray diffraction (XRD) and polarized light microscopy (PLM) are now mandatory for the USP test for asbestos in pharmaceutical talc. However, many companies still face practical implementation challenges.

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GMP and "Planned Deviations" - a Contradiction?

One discussion we have again and again at seminars is the question of planned changes. But such terminology can lead to problems.

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EMA publishes Consolidated ICH E6(R3) Guideline

The European Medicines Agency (EMA) published a consolidated version of the ICH E6(R3) Guideline. The ICH E6(R3) guideline builds on key concepts outlined in ICH E8(R1) Revision of General Considerations for Clinical Studies.

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