You will learn about the requirements for HVAC design

– New Annex 1 of the EU GMP Guide
– with sample documents related to ventilation systems

About HVAC, ventilation systems with new Annex 1

You will understand the requirements for the design, qualification, and GMP-compliant operation of a ventilation system. In operation, monitoring, and requalification, important details from the new Annex 1 must be observed. You will understand the differences between purely technical functions (ventilation systems in non-pharmaceutical buildings) and qualification according to Annex 15!

New Annex 1

The new version of Annex 1 of the EU GMP Guide for the Manufacture of Sterile Medicinal Products has been in effect since August 2024, incorporating all requirements. You will learn how to implement the requirements from the new Annex 1 of the EU GMP Guide, ISO 14644, and the FDA Sterility Guide into operational practice.

This seminar will thoroughly cover key regulatory frameworks such as the German Medicines Act (AMWHV), the EU GMP Guide with Annexes 1 and 15, and the role of ISO 14644 in the GMP context.

The focus is on the qualification of cleanroom technology systems (HVAC), including protection concepts, classification, and qualification according to Annex 1, as well as the development of a Validation Master Plan (VMP).

Participants will learn practical aspects of the content and execution of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as well as Worst-Case Scenarios.

Important aspects such as GMP risk assessments, monitoring, maintenance, and requalification according to the new Annex 1 will also be comprehensively discussed. The seminar is supplemented with illustrative sample documents, checklists, and practical application of Change Control and qualification planning.

Additional Modules

– Rooms, Air, and Technology: Design and Qualification of Rooms
– Rooms, Air, and Technology: Measurement Technology, Implementation according to the new Annex 1 and DIN ISO 14644