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GEP
Good Engineering Practice
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Good Engineering Practice GEP
Design of pharmaceutical site and process validation
Engineers Guide to Pharmaceuticals Production
Building Design and Construction Handbook
Premises. Official requirements
Premises. General requirements
Location, connection to other rooms
Size, area, height
Installation and supply of utilities
Lighting, ventilation, air-conditioning
Hygienic construction
Room book and layout
Material flow, personnel flow and layout
Room classes
Construction elements
Heating Ventilation Air Conditioning (HVAC)
Introduction
Room ventilation systems
Pure (100%) external air conditioning system
Central recirculating air/mixed air conditioning system
Decentralised recirculating air/mixed air conditioning system with central external air preparation
Pure recirculating air conditioning system
Systems for tempering and volume flow regulation
Control-systems of the air volume flows
Utilities for the operation of room ventilation systems
Filters
Principles for the design and planning of air conditioning ventilation systems
Design criteria for the ventilation of premises
Maintenance of air ventilation systems
Qualification of air conditioning ventilation systems
Facilities and Equipment. Introduction
Mechanical components
Construction and installation materials
GMP-compliant design characteristics
Electrical and pneumatic components
Control
Facility concepts
CIP (Cleaning in Place)
Isolator technology
Connected facilities
Examples of facility qualification
Design qualification
Installation qualification
Operational qualification
Technical documentation
Calibration
Maintenance
CIP (Cleaning in Place)
Containment (personnel protection) in solids handling
Process control systems
Hygienic (sanitary) design when using solids