Two and a half years after Annex 1 came into force, we would like to ask Xenia Dimont, GMP inspector for the government of Upper Bavaria, about her experiences with inspections of sterile manufacturers that have been carried out since then.

The demand for a documented contamination control strategy (CCS) has caused a lot of commotion. What do these documents look like in practice and do they fulfil the authority's requirements? The same question arises with regard to risk analyses – are they designed and used appropriately? Annex 1 requires the use of barrier systems – what does implementation currently look like in practice? What should be done if existing solutions are no longer compliant with the requirements of the new Annex 1? PUPSIT (Pre Use Post Sterilisation Integrity Test) was one of the topics that caused a lot of discussion during the revision of Annex 1. This test is generally required for all processes involving sterile filtration of products that cannot be sterilised in their final container. What practical experience has been gained in this regard?