Annex 1 of the EU guidelines on good manufacturing practice (GMP) for medicinal products outlines the requirements for the manufacture of sterile medicinal products in the EU.1 This article explores how the latest update to GMP Annex 1 impacts the sterile medicine production supply chain and how ready-to-use (RTU) containers, such as vials and cartridges, offer a time-efficient and cost-effective solution for compliance.
Introduction and Key Trends in Sterile Manufacturing
Sterile manufacturing plays a critical role in the global pharmaceutical supply chain. The market for sterile-manufactured drug products is expected to grow at a CAGR of 15% from 2022 to 2027,2 driven by biologics, biosimilars, and personalized medicines. This growth necessitates increased production capacity, efficiency, and quality while reducing complexity and waste.
However, expanding sterile capacity involves significant investment, long lead times, and regulatory compliance challenges. New regulations often require costly equipment upgrades, such as Restricted Access Barrier Systems (RABS) and isolators, which could increase the…
