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GMP News

ICH M4Q Guideline Updated

The draft of the updated guideline of the ICH entitled 'THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY M4Q(R2)' was published in May 2025 and is now available for public comment.

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FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls

A recent FDA Warning Letter highlights GMP violations at a U.S. manufacturer of over-the-counter (OTC) drug products, including missing microbiological testing, lack of stability data, and inadequate raw material controls.

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EFPIA Report on Current Inspections

The EFPIA has published its "Annual Regulatory GMP/GDP Inspection Survey 2024 Data", containing some interesting results that not everyone may have expected.

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