| Globales System für die Überwachung, Auswertung und Implementierung von Monographieänderungen und neuen Monographien in den relevanten Pharmakopöen Francisco Aguilar-Parrillaa, Conrad Schroedera, Richard Renfrowb, Thomas Ruaneb und Yuriko Isotanic Schering AG, Compendial Affairsa, Berlin; Berlex Laboratoriesb, Wayne (USA), und Nihon Schering K.K.c, Osaka (Japan)
This article describes a global system for the monitoring and evaluation of pharmacopoeial changes, change proposals and/or new monographs, and the distribution of the resulting information within a multinational pharmaceutical company. It also describes the initiation of the change management process for implementing these compendial changes into the in-house testing documents after the former have become official. Within the frame of this global system there are so-called Regional Managers of Compendial Affairs responsible for the respective region and Compendial Coordinators responsible for the respective site of the company. The relationship between both as well as between them and the responsible scientist during pharmacopoeial monitor-ing and evaluation is also described. |
