Validation (drug manufacture)

Validation (drug manufacture)

Jesse Russell Ronald Cohn

     

бумажная книга



ISBN: 978-5-5110-8304-9

High Quality Content by WIKIPEDIA articles! Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: