Good Manufacturing Practice ( GMP ) and Good Industrial Large Scale Practice ( GLSP )

Abstract

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