HVAC Qualification & Validation for GMP Facilities

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HVAC Qualification & Validation for GMP Facilities

Master Compliance for Sterile and Non-Sterile Facility HVAC Systems

This training provides a complete understanding of HVAC qualification and validation requirements in pharmaceutical and life-science facilities, covering both sterile and non-sterile environments. The course teaches how to evaluate, design, qualify, validate, operate, and maintain HVAC systems while ensuring they protect product quality, environmental control, and regulatory compliance. It also addresses industry gaps between engineering execution and GMP expectations, giving participants confidence to meet both regulatory and operational requirements.

Who Should Attend

Pharmaceutical Qualification & Validation Engineers / Managers
Maintenance Technicians / Engineers responsible for HVAC
Process / Project Engineers responsible for HVAC design or renovation
Quality Assurance Specialists / Managers
HVAC Calibration Technicians / Engineers
Compliance & Regulatory Professionals
Microbiology & Environmental Monitoring Specialists
Vendor / Contractor / Service Organization Engineers supplying HVAC solutions to pharma
Internal / External Quality Auditors

Course Objectives

By the end of the training, participants will be able to:

Understand all GMP trends for HVAC in sterile & non-sterile pharmaceutical industries
Interpret global GMP HVAC requirements related to Heating Ventilation & Air Conditioning (HVAC) systems
Distinguish between design vs operational engineering needs and regulatory needs
Establish environmental monitoring programmes for different production / cleanroom zones
Identify contamination and cross-contamination control parameters linked to HVAC design
Apply user requirement specifications (URS) and system lifecycle concepts during HVAC qualification
Prepare VMP, DQ, IQ, OQ & PQ documentation according to regulatory expectations
Harmonise differences between vendor specifications and ideal GMP engineering requirements
Evaluate and resolve HVAC compliance gaps during audits
Coordinate HVAC qualification activities across different departments

Course Outline

Module 1 – Fundamentals of GMP for HVAC

Overview of GMP expectations for HVAC in sterile & non-sterile facilities
Design principles and cleanroom airflow concepts
Application of global regulatory expectations

Module 2 – Documentation Systems

User Requirement Specification (URS)
System Design Specification (SDS)
Engineering drawings & supporting technical documentation

Module 3 – Qualification & Validation Lifecycle

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Change Control & Validation Maintenance

Module 4 – Environmental Monitoring

Cleanroom zoning and particle control
Monitoring plans for controlled environments
Trend analysis and compliance reporting

Module 5 – HVAC Quality Risk Management

HVAC risks linked to contamination and product exposure
Investigating failures & non-conformances
CAPA development for HVAC-related deviations

Module 6 – International Regulatory Expectations

FDA, EMA and WHO requirements for HVAC validation
Regional compliance differences for export markets
Expectations of inspectors during HVAC audits

Duration

Three days

Key Takeaways

Strong understanding of HVAC qualification & validation for life-science operations
Improved capability to manage HVAC audit responses and risk-based engineering decisions
Confidence to interpret global regulatory expectations and apply them in the field
Ability to coordinate and document full HVAC lifecycle including URS, VMP, DQ, IQ, OQ & PQ
Increased assurance of contamination control and product protection

Categories

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