Год выпуска: 2013
Автор: Vinod Thakor,Vidhi Manubhai Desai and Dr. Rajesh K Patel
Издательство: LAP Lambert Academic Publishing
Страниц: 80
ISBN: 9783659194894
Описание Validation is defined as the “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to the expected results.” (EC Guide to Good Manufacturing Practice, 1997). It is a requirement of GMP that each pharmaceutical manufacturer identify the validation work required to prove control of the critical aspects of their operations. Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, should be validated. |
