What Is New in Annex 1? | In this presentation, a selection of Annex 1 requirements with impact on facility and equipment engineering is discussed. Although several expectations were already embedded in cGMP for the last decade, a few letters (“PUPSIT”), words (“appropriate technologies (e.g. RABS, isolators…)”) or small sentences (“For aseptic processes, direct and indirect product contact parts should be sterilized”) have a major impact on design, qualification of facilities, utilities, equipment and operations. Even tough Annex 1 allows for justifications, risk assessments and “preferable” options, the expectations for the next decade are clearly spelled out. The key challenge for the pharmaceutical industry is the development of a risk based road map and strategy to implement design and operational improvements in close collaboration with engineering partners and equipment suppliers.