EMA clarifies application of GMP principles to ATMP starting materials The European Medicines Agency (EMA) issued a question-and-answer guidance on 23 April addressing how good manufacturing practices ...
An overview of the validation and qualification requirements introduced in the 2022 EU GMP Annex 1 revision, with a focus on ...
On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU ...
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will ...
The "GMP (Good Manufacturing Practice) Principles in Vaccine Manufacturing Training Course (Dec 10th - Dec 11th, 2025)" training has been added to ResearchAndMarkets.com's offering. In this two-day ...
GMP release and stability testing are indispensable elements of the pharmaceutical sector’s quality assurance strategy. These testing protocols not only ensure that pharmaceutical products are safe ...
New guidance released on 11 September by Health Canada makes changes to the way the agency classifies observations made during the course of a good manufacturing practice (GMP) inspection. The new ...
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