Drug, device and diagnostic manufacturing : the ultimate resource handbook /
DeSain, Carol.
Drug, device and diagnostic manufacturing : the ultimate resource handbook / by Carol DeSain. - Second edition. - xv, 429 pages ; 24 cm
Includes bibliographies and index.
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.
0935184384
Pharmaceutical industry--Standards.
Drug Industry--standards.
Research Design--standards.
Equipment and Supplies.
610.28 / D.C.D
Drug, device and diagnostic manufacturing : the ultimate resource handbook / by Carol DeSain. - Second edition. - xv, 429 pages ; 24 cm
Includes bibliographies and index.
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.
0935184384
Pharmaceutical industry--Standards.
Drug Industry--standards.
Research Design--standards.
Equipment and Supplies.
610.28 / D.C.D