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)
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
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
Facility concepts
CIP (Cleaning in Place)
Isolator technology
Connected facilities
Examples of facility qualification
Design qualification
Installation qualification
Operational qualification
Technical documentation  
CIP (Cleaning in Place)  
Containment (personnel protection) in solids handling  
Process control systems  
Hygienic (sanitary) design when using solids