Sterile manufacturing : regulations, processes, and guidelines

Introduction -- Data integrity compliance -- Risk based life cycle management -- FMEA manufacturing procedure -- Classified areas -- Sterile manufacturing facilities -- Personnel behaviors, personal protective equipment (PPE), and process flow -- Quality approach for systems validation -- Dedicated facilities -- Contamination -- Containment -- Suppliers -- Single use technologies (SUT) -- Master qualification plan (MQP) -- Water for injection (WFI) -- Integrated facility design -- Sterile techniques -- Compliance -- Controls -- Barriers, isolators, and RABS -- Quality risk management -- Equipment qualification (EQ) -- Process validation -- Change control -- Analytical testing of raw material quality -- Product life cycle -- Quality by design (QbD) -- Sterilization -- Cleaning validation -- Lyophilization.