HVAC Validation

Cleanroom Certification Reports and Their Role in Compliance

Cleanroom Certification Reports and Their Role in Compliance Cleanroom Certification Reports and Their Role in Compliance In the highly regulated pharmaceutical industry, ensuring that cleanrooms maintain the required standards for both environmental control and product integrity is paramount. A vital…

Aligning HVAC Validation with ICH Q9 Risk Management Principles

Aligning HVAC Validation with ICH Q9 Risk Management Principles Aligning HVAC Validation with ICH Q9 Risk Management Principles The validation of Heating, Ventilation, and Air Conditioning (HVAC) systems in pharmaceutical manufacturing is critical for ensuring product quality and compliance with…

Frequently Asked Questions by Inspectors About HVAC Systems

Frequently Asked Questions by Inspectors About HVAC Systems Frequently Asked Questions by Inspectors About HVAC Systems Step 1: Understand User Requirements Specification (URS) and Risk Assessment The foundation of any successful validation process begins with a clear understanding of the…