HVAC

FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations

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FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations The FDA Warning Letter reviewed in this article identifies significant Current Good Manufacturing Practice (CGMP) deficiencies at a pharmaceutical facility involved in the manufacture of sterile injectable drug products. The inspection was conducted under the authority of the U.S. Food and Drug Administration (FDA) … Read more

HVAC Validation in Pharma

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HVAC Validation in Pharma HVAC Validation = Control + Evidence + Compliance 1. DQ – Design QualificationVerify HVAC design meets GMP, process, room classification & user requirements. 2. IQ – Installation QualificationConfirm equipment, ducts, filters, sensors, controls and utilities are installed as per approved specifications. 3. OQ – Operational QualificationChallenge and verify HVAC operation under … Read more