EMEA: Concept paper on revision of Chapter 7 of the GMP Guide concerning \"outsourced GMP activities\"

The guidance in Chapter 7 is high level and generally still applicable to these other outsourced GMP activities but was drafted at a time when the outsourcing of GMP activities was principally restricted to only manufacture and analysis. Whilst the existing guiding principles outlined in Chapter 7 are clearly extendable to these out sourced activities, there is no explicit and unambiguous guidance as to whether such outsourced activities are inside or outside the scope of GMP guidance.