Good Manufacturing Practice (GMP) and Good Industrial Large Scale Practice (GLSP)
作者： Beth H. Junker
DOI: 10.1002/9780470054581.EIB352
关键词:
摘要: Key aspects of Good Manufacturing Practice (GMP) and Industrial Large Scale are presented an discussed. Major areas included facility regulatory guidelines, performance validation, investigations nonconformances deviations. Areas covered span from process scale equipment, laboratory utilities computer systems. Specific emphasis has been placed on steam-in-place clean-in-place, autoclave load patterns. Current best practices in each these presented, including concepts for design, operation, effectiveness studies, methods to reduce failures. An extensive bibliography coupled with data actual operating pilot plant give this chapter a strong applied foundation. Keywords: GMP; G(I)LSP; facility; equipment; validation; effectiveness studies; failures
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