Facilities Compliance

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, with limited resources, balancing 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 with 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 years + experience of qualification and validation. We are quite familiar with various situations and capture 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.

Facilities Compliance Related Services

Commission & Qualification Design Review Validation System Establishment Project & Process URS Risk Management / Risk Analysis Validation Master Plan Facilities & Equipment Qualification Processes Validation

Services

Facilities Compliance Related Services

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