EU-GMP-Leitfaden
GAMP 5
Qualifizierung
Rückverfolgbarkeit
(Traceability)Validierung
Verifizierung
Optimierung von Validierungsprojekten hinsichtlich GMP-Konformität – ein Beispiel aus der Praxis
Originale
Abstract
The optimization of validation projects concerning GMP conformity – an example from practice
Public authorities impose high requirements on validation activities in pharmaceutical manufacturing. Similar requirements exist concerning medical devices.
Required measures can demand numerous resources and expertise, are time-consuming and the demands for documentation are considerable. According to the EC Guide to Good Manufacturing Practice, which is mandatory for pharmaceutical manufacturers in the European Union, traceability of the data flow among the elements of validation processes is required.
In the scope of a bachelor thesis for the field of study Pharmaceutical Engineering, at Albstadt-Sigmaringen University, a verification of the validation of a packaging process for medical devices was performed using the software „GxP-Manager – Validation and Project LifeCycle“.
One aim was to verify a previous validation. A second aim was to analyze the efficiency and traceability of this kind of software. The following parameters were examined: regulatory requirements, specification of qualification steps, verification of test cases.
The procedure followed these steps: definition of laws and regulatory requirements relevant for the project, risk assessment, verification of specified requirements. In addition, visualization techniques were analyzed and their validation documentation was modified.
In summary it can be stated that using this software in the analyzed qualification/validation project, improved clarity, assured traceability and achieved a high degree of conformity regarding regulatory requirements.
· 2 Jotec GmbH, Hechingen 3 CVO Europe, Basel (Schweiz) 4 GxP-Manager, Lyon (Frankreich)
Korrespondenz:
Prof. Dr. Ingrid Müller, Hochschule Albstadt-Sigmaringen, Anton-Günther-Straße 51, 72488 Sigmaringen (Germany), e-mail: mueller@hs-albsig.de
Key Words
Zusammenfassung
Behörden stellen hohe Anforderungen an die Validierung bei der
