Drug, device and diagnostic manufacturing : the ultimate resource handbook - DeSain, Carol (Buffalo Grove, Ill. : Interpharm Press, Inc., 1993)
Biomedical research/design -- Biomedical product development -- Regulatory requirements -- Facility qualification master protocol -- Documentation and document control -- Departmental organization/responsibilities -- Master validation protocol -- Quality assurance monitoring and control programs -- Clean rooms for aseptic processing -- Endotoxin testing and depyrogenation techniques -- Lyophilization -- Particulate monitoring and control for parenteral and implantable product manufacturing -- Physical sterilization techniques and validation -- Stability testing programs -- Disinfection programs -- Water purification and water quality testing -- Computer controlled process validation -- Safety programs.
Includes bibliographies and index.
Keywords: Pharmaceutical industry -- Standards; Drug Industry -- standards; Research Design -- standards; Equipment and Supplies