This presentation covers a short introduction to the overall topic of Annex 1 and its history. Besides having the latest changes compared to previous version (e.g. contamination control strategy), it focuses on the most important influence factors in the design and implementation of new fill-finish facilities. Some of the covered items are cleanroom classifications, machine design, air velocity measurement, first air design, glove testing, reduction of manual interventions, handling of direct and indirect product contacting parts, etc.