TY  - BOOK
AU  - DeSain,Carol
TI  - Drug, device and diagnostic manufacturing: the ultimate resource handbook 
SN  - 0935184384
U1  - 610.28 22
PY  - 1993///
CY  - Buffalo Grove, Ill.
PB  - Interpharm Press, Inc.
KW  - Pharmaceutical industry
KW  - Standards
KW  - Drug Industry
KW  - standards
KW  - Research Design
KW  - Equipment and Supplies
N1  - 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
ER  -