CoP HVAC & Sustainable Facilities


About

In der ISPE D/A/CH engagieren sich Mitglieder aktiv in regionalen Arbeitsgruppen und den CoP´s (Communities of Practice). Durch fach-/themenorientierte Workshops, Diskussionen und Kommunikation werden Best Practice Arbeitspapiere und Vorgehensweisen im sensiblen Umfeld der Patientensicherheit entwickelt. Sie dienen der Industrie und den Behörden als Guidelines. Mitglieder der ISPE D/A/CH partizipieren an den ISPE Guides.

Einleitung

Unser Ziel: Betreibern, Planern, Herstellern und Interessierten, die im beruflichen Alltag mit HVAC und Facility Design zu tun haben, eine Diskussionsplattform für Fachthemen und zum Austausch von Erfahrungen zu bieten. Diese Zielsetzung wird durch jährlich stattfindende Fachdiskussionen zu Themen aus dem Bereich “HVAC & Sustainable Facilities” unterstützt. Zusätzlich findet regelmäßig ein Austausch mit den CoP’s anderer Affiliates statt.


Die Arbeitsgruppe wird die länderspezifischen Anforderungen an das „Facility Design“ (insbesondere Mexiko, Russland und China) aufzeigen und ein gemeinsames Verständnis, basierend auf dem Feedback der Arbeitsgruppenteilnehmer, entwickeln.

GROUP CHARTER

ISPE Regional DACH Community of Practice / CoP “HVAC & Sustainable Facilities“

CURRENT INDUSTRY STANDARD

In the last years pharmaceutical industry faced more country specific requirements for facility design (e.g. Pressure cascades with differential values dP, air change rates ACR, etc.). E.g. Specific Values (dP/ACR) have been published specifically in these country guidelines which lead to different conclusions for design engineering / operational engineering and other stakeholders.
Specifically countries like Mexico, Russia and China updated their country guidelines, or request region specific design.

VISION

Develop a global common understanding and best practices, based on the regional experiences and the feedback from ISPE members.

MISSION

The developed recommendations & best practices incl. their justification should be shared and published as recommendations in the ISPE community. This global common understanding may support a common view for the regional regulatory authorities, as these are essential partners ensuring GMP manufacturing.
The ISPE regional DACH CoP “HVAC & Sustainable Facilities “offers a cross functional working platform for relevant experts from stakeholders to exchange and align on main facility design requirements.

OBJECTIVES

The kick off and the resulting workshops provide different aspects of implementing country specific standards. The objectives can be enlarged to other upcoming guidelines from further countries in a following phase.
The published paper should allow developing a common base for argumentation.
To ensure that both aspects of this topic (engineering and quality) are considered, the set‐up of the workshop is to have representatives of ISPE members experienced in pharma manufacturing and quality operations.

MEMBERSHIP

Members of the ISPE regional DACH CoP “HVAC & Sustainable Facilities” are ISPE members by default.
Additional Members are welcomed from regulatory agencies or functions.
Expectations on team member commitment are participation in regular quarterly telecons and two face to face meetings per year.
Content‐wise: contribute and share personal expertise and knowledge as compatible with the own job description and applicable codes from either ISPE or employer.

ORGANISATION AND COMMUNICATION

Authors:
Paolo Gianolini, Takeda (Chair)
Christian Beyer , Bayer Consumer Health (Co‐Chair)
Daniela Allhenn, (Bundesverband der Arzneimittel‐Hersteller e.V./BAH)
(August, 2018)

Steering Comittee

Dr. Daniela Allhenn,
Bundesverband der Arzneimittel‐Hersteller e.V./BAH
 
Dr. Christian Beyer,
Co-Chair Bayer Consumer Health
 
Paolo Gianolini, Chair
Takeda