GxP PROJECT CONTROL

Project control is already an interesting field in itself, but it gets really interesting when you get into GxP project controlling. The pharmaceutical sector has complex terms, dependencies and regulations. To be able to offer very good GxP project control, you need one thing above all: experience, as this does not build up overnight in the complex pharmaceutical environment. GBM-Essen Projektmanagement GmbH has been working in the pharmaceutical industry for almost 20 years and as Team Leader Pharma I can look back with pride on our projects, our well-known customers and the experience we have built up. In recent years, we have managed key projects in pharmaceutical history for clients such as Novartis, GSK and BioNTech and we are grateful for the trust placed in us and the good cooperation over the past decades.

GxP has to do with set standards and quality and this is what our team offers out of conviction true to our motto "conduct and convince". A project team loses valuable time if a project manager first has to learn the basics of the pharmaceutical sector in a lengthy process. Our employees are trained in the world of pharmaceuticals from day one and have everything they need to take on tasks straight away and impress with their performance.

We know what an "OQ" involves and what dependencies there are on other project activities. For us, an "autoclave" is more than just a "device" and we know why it is better to order bioindicators for its performance qualification sooner rather than later. For us, the word "BImSchG" is not an unintentional result of fingers being too nimble on the keyboard, but a necessary application under the Federal Immission Control Act and we can even tell you when you need the application according to §8a and what approval times need to be planned for. Do you need assistance with tracking source documents for regulatory submission so as not to jeopardize your action date for US submission? GBM-Essen Projektmananagement GmbH has specially developed status dashboards for this important project phase. Have you considered whether you need a media simulation or APS runs before your process validation or comparability runs? We already have the processes for this in our aggregated statistical project analysis. Naturally anonymized, as we protect confidential information. This is also important in the pharmaceutical world: an external partner you can trust. That's why we are a Quality Austria-certified project management company that adheres to the highest security standards. Our employees are specially trained in customer-specific SOPs and confidentiality, and regularly take part in internal training courses. Our IT infrastructure is secured with multi-layered redundancy at software, hardware and operational level and is constantly updated. These comprehensive measures protect confidential information and ensure the reliability of our systems - a decisive advantage in the pharmaceutical industry, where trust and data security are essential.

Would you like to find out more? Then accompany me through the wonderful world of pharmaceuticals and GxP project management, which has been our vocation rather than just our profession for almost 20 years: