ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 4.1: Design buildings and material and people flows to ease cleaning and maintenance, prevent mix-ups and contamination, and provide defined areas for each activity

What does 4.1 require?

Buildings and facilities should be sited, designed and built to suit cleaning, maintenance and the type and stage of manufacture, and to minimise contamination (including objectionable micro-organisms where a microbiological specification applies). They should have room for orderly placement of equipment and materials. Equipment that itself protects the material, such as closed systems, may stand outdoors. Flows of materials and people should be laid out to avoid mix-ups and contamination. Defined areas or equivalent control systems should exist for receiving, identifying, sampling and quarantining incoming materials; quarantine of intermediates and APIs before disposition; sampling; holding rejected materials; storing released materials; production; packaging and labelling; and laboratory work. Clean washing and toilet facilities with suitable water, soap or detergent and drying means should be separate from but convenient to manufacturing areas, with showering or changing facilities where needed. Laboratories should normally be separate from production, though in-process testing labs may sit in production areas if neither affects the other.