Validating Pharmaceutical System: Good Computer Practice in Life Science Manufacturing

This highly readable text offers a pragmatic approach to the validation of automated/computerized systems, an essential core task when establishing and maintaining compliance with global regulatory authorities, such as the FDA and the MHRA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle, using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice. software configuration specification, validation life cycle activities, application software validation, predicate rule requirements, systems quality group, acceptance testing protocols, contract acceptor, overall validation process, electronic signature requirements, validation consultant, validation rationale, applicable predicate rules, postal audit, computer systems validation, master document list, life cycle documentation, contract giver, installation qualification protocols, final validation report, system acceptance testing, healthcare manufacturer, good automated manufacturing practice, other life cycle phases, documented risk assessment, solid dose forms