• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart


Quality Agreement Standard...
As the pharmaceutical...

Question of the Week

Who is responsible for process validation?

According to Chapter 2.5 and 2.7 of the EU GMP Guide, the Head of Production is responsible for validation in the manufacturing area. He/she must make sure that drug products are duly manufactured according to the submission file for marketing authorisation and the best available pharmaceutical science.

[GMP MANUAL, Chapter 7.A.1.2]

Back ...