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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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GMP non-Compliance Reports for two Cannabis Sites

Malta's Medicines Authority recently issued two GMP non-compliance statements: One  to a manufacturer of cannabis-based medicinal products and another to a Quality Control testing laboratory for the analytical testing of non-sterile dosage forms (specifically for  medical Cannabis products).

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New Ph. Eur. Chapter for Estragole Determination

A new European Pharmacopoeia (Ph. Eur.) chapter 2.8.27. Determination of Estragole has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.

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