The Life Sciences & Health sector is characterized by complex and demanding quality legislation and regulations (GxP, collective name for, among others, GMP, GDP, GLP, GCP), compliance with applicable laws and regulations is crucial for success.
An important aspect of compliance concerns the scientific and documented evidence that processes and equipment can produce consistently and with the right quality product. A proper execution of commissioning and qualification of equipment, utilities and facilities and validation of (production) processes, (analysis) methods and IT applications are therefore important conditions for achieving innovations and being approved. Or to (continue to) produce existing products.
It appears that SMEs are regularly surprised at a (too) late stage by compliance requirements that they are not prepared for. With the result that developments (for example the final development of a new medical product) are delayed or even blocked. Whether the production and sale of an existing product is at risk.
Against this background, the GxP expertise center for the southern part of the Netherlands is established. SMEs in the LS & H discipline can go here with questions about validation, qualification, quality and compliance of GxP-obligatory systems, processes, facilities and facilities. The expertise center aims to play an important supporting role for small and medium-sized companies that often find their way difficult (in time) in the complex regulations.
The expertise center aims:
- Support companies and organizations in a low-threshold way in their questions about quality and compliance of GxP-obligatory systems, processes, facilities and facilities. The topics commissioning, qualification and validation form a spearhead.
- Making LS & H SMEs more aware of the regulatory obligations regarding GxP-obligatory systems, processes, facilities and facilities at an earlier stage of product development.
- Making available a knowledge network and communication platform for LS & H professionals.
The expertise center can best be characterized as a helpdesk where LS & H SME can easily access 2nd and 3rd line support in the area of quality and compliance of GxP-obligatory systems, processes, facilities and facilities. The center will function primarily as a virtual knowledge plaza where organizations and SMEs in the LS & H sector digitally call for advice, consultation and support. Additionally, meetings (events / workshops) can take place on location where professionals can learn and exchange knowledge.
Although the expertise center mainly derives its strength from its network and the sharing of knowledge, a confidentiality agreement is concluded in advance where necessary and your question is handled bilaterally and in strict confidence. The expertise center is not for profit and its primary objective is to optimally utilize the innovative strength of the top sector life sciences & health.
For more information about this initiative contact Pharmsupport via e-mail.
Note: The GxP expertise center is part of the Pharmability program: An initiative made possible by financial support from the European Regional Development Fund and the Province of Noord-Brabant.