You will learn about GMP requirements for cleanrooms

– With extensive sample documents
– New Annex 1

Room, Air, and Measurement Technology: An interconnected Quality System

In addition to the equipment and machinery, the rooms have a direct influence on the quality of pharmaceutical and active ingredient manufacturing.

What you will learn

The design of rooms and ventilation systems significantly influences the potential level of contamination with both living and non-living particles. You will learn how to translate knowledge of room air technology and room design into concrete requirements.

This seminar covers the fundamentals of qualification and validation of rooms, including legal requirements such as AMWHV, EU GMP guidelines with the new Annex 1, and FDA regulations.

Participants will understand why rooms need to be qualified and will learn methods such as risk analyses and system impact assessments based on ISPE Baseline Vol. 5.

Practical case studies demonstrate how to handle typical challenges, such as sealing penetrations, and illustrate the phases of qualification from Design Qualification (DQ) to Performance Qualification (PQ). Additionally, the specific requirements for hygiene zones, room concepts, and pass-through systems are addressed to ensure zone-appropriate room design according to relevant regulations.

The seminar is complemented by an introduction to documentation, design requirements, and examples of room books, including qualification and validation matrices.

Annex 1 in effect since 2024!

The new version of Annex 1 of the EU GMP Guide for the Manufacture of Sterile Medicinal Products has been in effect since August 2023. Only one item (8.123) came into force a year later, on August 25, 2024. You will learn how to implement the requirements from the new Annex 1 of the EU GMP Guide, ISO 14644, and the FDA Sterile Guide into operational practice.

Additional modules

– Rooms, Air, and Technology: Ventilation systems
– Rooms, Air, and Technology: Measurement technology, implementation according to Annex 1 new and DIN ISO 14644