GMP- FAT & SAT Konzept und Durchführung mit praxisnahen Fallbeispielen und Templates

The book "GMP - FAT & SAT Concept and Implementation with Practical Case Studies and Templates" offers a comprehensive introduction to the creation of FAT (Factory Acceptance Test) and SAT (Site Acceptance Test) documents, as well as the associated test protocols. It is based on the guidelines of Annex 15 of the EU-GMP, which are crucial for validation and qualification in the pharmaceutical industry. The content is tailored for professionals in pharmaceutical engineering as well as students and trainees in the fields of chemistry and pharmaceutical engineering. Through practical case studies and templates, it enhances the understanding of the complex requirements and processes in the pharmaceutical industry. The book serves as a valuable reference for anyone involved in quality assurance and validation processes in the pharmaceutical sector.