The new draft guidance describes the obligations of contracting parties, the delimitation of responsibilities and how to ensure the quality, safety and efficacy of medicinal products in the manufacture of contracts. It applies to the commercial manufacture of:- pharmaceutical substances (APIs or pharmaceutical substances or their intermediate products), – finished medicinal products, – combination products and – biological medicinal products (v) GENERICO Ordered manufacturing does not oblige NEW ALPHA to place orders after the expiry of the shelf life, unless NEW ALPHA has previously given its consent in writing. . . .