Validation: Essential Requirement in Pharmaceutical Industries. Text Book

      Аннотация: In the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries, validation is 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: Cleaning validation Process validation Analytical method validation Computer system validation this book give the basic idea to the student for under standing to how to validate the process an other cleaning validation

Ключевые слова: validation, Calibration, Linearity, cleaning validation