Qualifizierung von Lüftungsanlagen und Reinräumen Konzeption − Projektmanagement − Ausführung Stefan Erens Testo industrial services GmbH, Kirchzarten Korrespondenz: Stefan Erens, Business-/Projectmanager Qualification/Validation, Gewerbestr. 3, 79199 Kirchzarten (Germany) Qualification of Air Condition, Ventilation and Clean Rooms / Concept − Project management − Implementation The GMP and engineer standards for pharmaceutical productions are depending on a lot of influences. One of the most important influences on the production of pharmaceuticals and therefore influencing the quality of the products, is the climate room conditions.
Therefore the qualification of HVAC Systems and clean rooms is a significant part of the quality assurance concept (direct impact). For this reason the commissioning and also the qualification testing should be oriented close to the qualification V-Model, which one is an expedient project tool for this challenge.
The detail phases of the qualification (DQ, IQ, OQ, PQ) and their test approaches should be connected complementary to the Commissioning phases (Design, Construction, Commissioning, Performance measurements). That means that for the different assembly sections (air condition / ventilation plants and clean rooms) separate validation activities are required, but in parts it could be reasonable to do the testing of both assemblies simultaneously.
A superior Validation Master Plan can be a helpful project tool used as project management tool to coordinate all those different duties and responsibilities.
As a fact it is the responsibility of the project management team to schedule and to organize the execution of all the above named activities.
The acquisition, evaluation and the assignment of all relevant requirements is a key aspect for a GMP conform realization of a project. The assignment responding out of the requirements for the necessary actions (technical, organizational or compliance) should take place because of different decision criteria (e.g. technical competence, planning competence or measurement technology competence). Also experiences inside the pharmaceutical environment should be decision criteria. Key words Comissioning • Lüftungsanlagen • Projektmanagement • Qualifizierung • Reinräume • Validierungsmasterplan | 
