How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

Manufacturers of sterile medicinal product. Entire supply chains entered a new era with the August 2023 EU GMP Annex 1 updates, all of which ultimately focus on enhanced public health protection. This article outlines the pharmaceutical manufacturers requirements to develop a comprehensive contamination control strategy that documents their assurance of sterile drug quality and patient safety.