Qualification and validation are the key GMP inspection topics and also high challenges for all the life science companies like pharmaceuticals, especially for the new set-up plants or workshops. We have seen, by limited resources, to meet the schedule and the target GMP inspection requirements, becomes the industry focus. Beside all, with the continuous updating of the concepts and practices of qualification and validation in the industry China and oversee, companies must be able to quickly understand and catch up the dynamics and be able to transfer them into practice. This is another big challenge!
gempex executes and guides many qualification and validation projects every year based on our 20+ experienceof qualification and validation. We are quite familiar with various situations and captures the industry difficulties and troubles. With all these valuable experiences and knowledge, we establish advanced qualification and validation concepts, which can assist companies to achieve target GMP compliance goals by the most economical and practical strategies.
