Qualification

Picking HVAC Guidance Needles in PIC/S Haystack

Picking HVAC Guidance Needles in PIC/S Haystack FDA GMP regulations are legally binding for drugs marketed in the US. Similarly, EU GMP regulations are binding for the EU market. But what about the rest of the world? That’s where PIC/S (Pharmaceutical Inspection Co-operation Scheme) comes in. While not legally binding, it offers harmonized guidance that […]

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How to Raise the Quality of HVAC Qualification

How to Raise the Quality of HVAC Qualification The 3-day HVAC qualification testing of a small warehouse in our fast-paced project had just ended. The testing included recording the warehouse’s temperature (T) and relative humidity (RH) using 29 sensors: 26 portable T & RH loggers and 3 EMS (Environmental Monitoring System) sensors: two (2) temperature

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What if You’re Stuck on a Flight With Nothing to Read Except ISO 14644

What if You’re Stuck on a Flight With Nothing to Read Except ISO 14644 Hope it never happens in reality but only in the imagination: It’s a long-haul budget flight with no onboard entertainment like movies, magazines, or newspapers. You’re desperately trying to sleep but the more you try, the more you miss it. Seeing

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