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Autor:
Sven Alexander Moritz, Alexander Nezlin, Timothy E. Orzula, Ana Isabel Esteban Nunez, Bernhard Hinsch, Daniel Taylor
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 76:75-87
Pharmaceutical quality systems (PQS) according to ICH Q10 require the identification of processes that need to be measured. Designing and maintaining a metrics system in a way that serves its purpose well requires careful consideration of various asp