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Qdossier Qsauri
"C"

clean room
Guideline or reference source
ECA GAMP5 Approach and Risk Management
FDASDP Sterile drug products produced by asceptic processing - CGMP
Definition
A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.
Related Term
clean area
 

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