New international regulations, innovative new products and intensified competition are increasingly putting pressure on manufacturers of pharmaceuticals, especially in regards to topics such as qualification and validation. Modern, efficient and cost-effective process models need to be found to address these issued.
The specialist publication “Modern Qualification” by Gert Moelgaard, Chairman of the ECA European Compliance Academy and Ralf Gengenbach, Managing Director gempex GmbH, outlines the topic, also in view of international competition, provides an overview of regulatory requirements, methods and common practices, and describes the advantages of integrated qualification and validation. It introduces the ECA Guide “Modern Qualification”, which identifies possible problem-solving approaches and emphasises the importance of critical aspects-based risk assessment (CARA). It is a guideline that recommends the early involvement of suppliers and provides a broad range of examples and templates to pave the way from theory to practice; a plea for greater efficiency in ensuring the realisation of compliance, also and especially in international competition.
The publication is available for download under gempex.com/GMP-knowlwdge.