Quality Control and sub-contracted manufacturers

Frequently, manufacturers responsible for Quality Control (QC sites) delegate certain tests (e.g. sterility testing) to sub-contracted sites. The results obtained are included in the Certificate of Analysis (CoA) of the approved QC site. These QC sites operate in such a way that these manufacturers are qualified and managed by the approved QC site. (Re)qualification takes places in accordance with EU GMP. In certain cases, these sub-contracted sites therefore do not appear in Module 32p31. In Switzerland, sub-contracted manufacturers (QC sites) have to be listed both under 32p31 in Module 3 and under 1.2.2.2 in the form ‘Manufacturer Information’ in Module 1. The basis for this is described in the «Guideline on manufacture of the finished dosage form» (EMA/CHMP/QWP/245074/2015, dated 04 July 2017).