HVAC system is the most important system in the HVAC system. In the pharmaceutical industry, documentation is the most important as evidence.
Following are the document required for the HVAC system.
-Verification of design documentation HVAC System:
-Qualification HVAC System.
-Qualification includes design qualification, installation qualification, operation qualification, performance qualification.
-Validation of HVAC system.
-Operating procedures of the HVAC.
-Maintenance instructions
-Maintenance records
-Training records
-Environmental records
-filter cleaning record
-Temperature and humidity records for HVAC system
-Pressure records for HVAC system.
In the pharmaceutical industry, HVAC systems play a critical role in maintaining cleanroom conditions and product integrity. Proper documentation is essential to ensure regulatory compliance, system validation, and quality assurance. Key documents include Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Additionally, system layout drawings, airflow diagrams, filter integrity test reports, calibration records, and maintenance logs are required. These documents collectively support Good Manufacturing Practices (GMP) and help demonstrate that the HVAC system consistently performs as intended. Regulatory bodies like the FDA and WHO expect thorough documentation to validate environmental control in pharmaceutical manufacturing facilities.
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