New regulations for the manufacture of sterile drugs also mean that single-use technology suppliers have to take action. ’Ideally, we should be involved at the design stage.’

The long-awaited final version of GMP Annex 1 was published in August 2022, and with a one-year implementation period, this means that these new regulations have actually been in force since August this year. For those who have lost track for a moment, this refers to the EU regulations around so-called Good Manufacturing Practices (GMP). This Annex 1 is an extension of those regulations and describes the requirements that must be met in the manufacture of sterile medicinal products. Think of products that are administered by injection or infusion, such as vaccines or antibody-based therapies.