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- ANNEX 1
Increased requirements for aseptic safety when feeding packaging and stoppers
Annex 1 and fill-and-finish processes: effects on aseptic packaging and stopper feeding
With the implementation of the EU GMP Annex 1 ("Manufacture of Sterile Medicinal Products"), pharmaceutical companies are facing new challenges, particularly in the fill-and-finish processes—the filling and final processing of medicinal products. Annex 1 introduces expanded requirements for the op…