The Commissioning & Qualification and Validation (C&Q&V) BeNeLux Community of Practice (COP) will be a new COP linked to the Belgium and Netherlands affiliate of the ISPE. The COP will consist of a Steering Committee (SC) and members.
The C&Q&V COP is a group of Life Science based practitioners in relation to process* and system** compliance and who will come together to promote the understanding of the regulation requirements governing the use of these systems and processes. The C&Q&V COP will co-operate with the ISPE Affiliates and/or other COPs in support of ISPE’s strategic direction in connecting Life Science knowledge and attracting new members. Whenever possible, the C&Q&V COP will form relationships, coordinated through ISPE, with likeminded industry associations to share knowledge and best practices. The C&Q&V COP will partner with suppliers to identify and share best practices in order to have a positive influence on the quality of systems and processes used in the Life Science Industry.
* Defined as: all processes relevant for GxP, such as;
- Manufacturing Processes
- Cleaning processes
- Supply chain process / Controlled Transport
** An organization of engineering components, which have a defined operational function, e.g., piping, instrumentation, equipment, facilities, computer hardware, computer software, etc. (source: ISPE glossary; www.ispe.org/glossary)
- To be recognized as the expert and knowledge centre on systems and processes C&Q&V in relation to Quality Management and Regulatory Compliance;
- Share relevant information, best practices, improvements and interpretations of the legislation and guidance in relation to System Lifecycle commissioning & qualification and Product Lifecycle validation.
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