The guidance applies to marketing authorization holders and drug manufacturers (including active pharmaceutical ingredient DMF filers) that manufacture (medical) products in shared facilities on the commercialized pharmaceutical production line. The products include active pharmaceutical ingredients (APIs), test samples produced at a non-commercialized scale, investigational drugs for clinical trials, model materials for technology validation, etc. 

The guidance can also be a reference for producing different drugs with shared facilities on a non-commercialized production line for investigational drugs used in clinical trials.