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The European Union (EU) has implemented stringent regulations and quality standards for the importation of pharmaceutical products to ensure patient safety and product efficacy. Two critical aspects of this regulatory framework are the EU Batch Release and Good Manufacturing Practice (GMP) requirements. In this blog post, we will explore the significance of EU Batch Release and GMP requirements for the importation of pharmaceuticals into the EU market.
Computerized System Validation is crucial in the pharmaceutical sector to ensure the operational efficiency of electronic systems. It is a continuous process that begins with identifying the functional requirements and involves comprehensive testing to confirm that the system remains reliable and compliant with regulatory requirements.
Our LIMS is integrated in all our processes and basically acts as an additional member of our team, automating workflows and tracking all the important sample information, data, workflows, and QA/QC results. Furthermore, we are able to log in not only from our computers and labtops but also using all different kind of devices, for example iPads, Surface etc. The Microsoft HoloLens2 is the next device which we are connecting to the LIMS System in order to document processes handsfree
UHPLC technology provides high analysis speed, better chromatographic resolution, performs more sensitive analysis, consumes less time, reduces solvent consumption. Although these facts are proven, the implementation if this technology shows only slow progress within the quality control of pharmaceutical.
We have developed a strategy how methods can be transformed and all the benefits including cost savings can be seen in short time.
We provide Business case, Regulatory Strategy and Registration Documents, Method Validation Documents according to ICH, Testing Procedure and Project Plan.