This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.4.1.1 Change Management System and Its Various Subsystems The fundamentals of a change management system must be clearly delineated in a corporate quality manual or policy. Current industry standard mandates that a corporationanbsp;...
|Title||:||Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics|
|Publisher||:||CRC Press - 2003-12-09|