EMA recently issued a Q&A addressing supply chain traceability expectations for medicinal gases to support the revision to Annex 6 to the EU GMP Guide. The revised annex on “The Manufacture of Medicinal Gases” was adopted by the European Commission at the end of January and became effective at the beginning of August.
Questions and answers to frequently asked questions on GMP topics are published periodically by EMA following discussion and agreement of its GMP/GDP Inspectors Working Group. The Q&A on Annex 6 focuses on the “traceability” of medicinal gas packaging components, which are of particular concern because of their reuse.
[More on the traceability issue and the revised Annex 6 is provided for subscribers here.]