What Will You Get if You Pass FDA’s GMP Regulations Through a Special HVAC Filter If you enter a forest but do not know what to look for or where to go, chances are you’ll either get lost or simply have a random trip. GMP regulations by the FDA, EU, WHO, etc. are a couple […]
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What’s HVAC Design Qualification (DQ) and How To Do It? No project starts with a strategy to ignore the quality of design, but in the power play of a typical biopharma project, it happens: Under the severe constraints of time and cost, the design gets rushed and its quality gets crushed. However, the quality of
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How to Set Alarm Delays for GMP Differential Pressure Alarms Among all the HVAC-related GMP requirements, one of the most critical is the pressure difference between rooms of different grades. According to Annex-1 (EU GMP), a minimum of 10 Pa pressure difference should be maintained between rooms of different grades. The regulations also require a
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