The approved variation enables Upperton to commence GMP manufacture of sterile investigational medicinal products from the purpose-built facility, expanding the company’s integrated development and ...
One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...
The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which ...
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