Eudralex Volume 4 Technical Agreement
Section 7.15 clearly provides for continuous monitoring of all organic carbon (TOC) and conductivity (lines 710-711). There is a typical reaction when you research which rules to consider. Most of them tend to focus their efforts on the FDA`s 21 CFR Part 11 because of their international reach, but if most of your efforts are focused on Europe, you need to follow some of the guidelines you need to follow on this side of the pond. . Volume 4 of `Prescriptions for medicinal products in the European Union` contains guidelines for the interpretation of the principles and guidelines of good manufacturing practice for medicinal products for human and veterinary use in accordance with Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC and Directive 91/412/EEC respectively. . . . . .