During the past two years, gempex China -THE GMP EXPERT- has supported BASF with GMP services during the construction of a new PVP production plant in Shanghai, China. The facility is now in operation and product validation batches have been produced successfully, concluding the project with a fully GMP compliant facility.
PVP – polyvinylpyrrolidone – is an important excipient used worldwide which, in addition to other applications, is used in tablets to enhance the stability of the API (active pharmaceutical ingredient). PVP is also used in the food and cosmetic industries. With this new plant, BASF – as a world leader in PVP production – is meeting state-of-the-art as well as local and international GMP requirements.
gempex China provided a comprehensive range of GMP consulting and execution services for this project. The services included but were not limited to the preparation of URS, conducting risk assessments, performing design reviews, planning and execution of all related qualification & validation activities for production equipment, QC equipment as well as for IT systems, preparation of GMP documents (SOPs) and frequent GMP training.
gempex aims to ensure consistent quality and GMP compliance for its customers at all times.