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USP Guidelines on Environmental Control including related Guideline
"Monitoring can not identify and quantify all microbial contaminants present.”
“Microbiological monitoring of a clean room is technically a semi-quantitative exercise, given the limitations in sampling equipment."
Guideline
Current Good Manufacturing Practices (cGMP)
Current Good Manufacturing Practices (cGMP) are regulations enforced by the US Food and Drug Administration (FDA) that provide systems to ensure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers adequately control manufacturing operations.
Guideline
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US FDA Requirements for Pharmaceuticals
(21 CFR 211.46) HVAC & Environmental Controls
Proper air handling with HEPA/appropriate filtration
Positive/negative air pressure controls based on product risk
AHU qualification & periodic monitoring
Separate air-handling for potent/toxic materials
Temperature & humidity monitoring with deviation controls
Guideline