Qualification and validation in GMP are a series of activities in which an enterprise provides documentary evidence to show that the plants, facilities, equipment and systems can operate correctly and meet their intended purpose. Especially for new plants or workshops, facility and equipment qualification are one essential part of the project and as the most intensive activities of the GMP work, and as one of the highlight of the authority inspection in the later phase. At the same time, with the continuous updating of the concept and practice of qualification in the western pharmaceutical industry, timely catching the direction and requirements of qualification has become a major challenge for pharmaceutical companies to pass EU and US cGMP inspection. Then, how to solve those questions for the enterprises under such a situation of high regulatory requirements with heavy project workload and strict schedule requirements. It's a question!
gempex has over 20 years of experience in GMP qualification, and we deeply know the nature of qualification work and the challenges faced by enterprises. Our experts apply modern validation concepts and combine with actual project experience, and we can provide reliable validation solutions for our customers in the global life sciences fields.
We can provide GMP qualification services for plant or facilities, storage equipment, production equipment, laboratory equipment and instruments as well as utilities (such as air conditioning systems, purified water systems, compressed air systems, temperature control systems, etc.).
Professional and competent support to customers to save time and cost
Fully control the risk in the qualification to avoid irreparable defects
Credible qualification documents to ensure compliance with official inspection and audit
including proposal writing or review, implementation, report or review.
