The draft version of Annex 1 "Manufacture of Sterile Medicinal Products" is the first revision since 2008.
The document addresses a number of issues that have emerged in recent years. For example it provides information on the qualification of cleanroom that take revisions to ISO 14644 standards into account.
The revision – which is more than double the length of the current version – also introduces a new section on “utilities,” which covers the water, sterilization, filtration and cooling systems used in the production of sterile pharmaceuticals.
It outlines potential risks associated with single-use systems (SUS), touching on issues like contact surfaces, fragility of connectors and the increased complexity of such systems.
The commission advises that, “SUS should be designed so as to maintain integrity during the intended operational conditions and duration, especially the structural integrity of the single use components under extreme process and transport conditions such as during freeze and thaw processes.”
The European Commission (EC) opened the document up for until the end of March.