Research Of Qualification And Validation For New Biopharmaceutical CMO Facility Utility And Equipment

With the rapid development of biological pharmaceutical industry,Biopharmaceutical companies in China are facing with the severe survival test,but in the meantime the development also brings a good opportunity for biopharmaceutical companies.The national policy keeps pace with the times,promote the rapid development of biopharmaceutical contract manufacture,motivate the biopharmaceutical company turned into “Service Platform”,and help biopharmaceutical R&D Company occupy a favorable position in the market and seize market share.It is the responsibility of biopharmaceutical contract manufacture organization(CMO)to facilitate the biopharmaceutical manufacture facility utility and equipment to comply with the highest international standards fastest and most cost-effectively.To ensure the flexibility of process,reduce the cost of facility and utility and speed up the commercial phase,Biopharmaceutical CMO companies always implement single use technology and isolators in the whole process.Only Class C and D are required for this kind of facilities.To start the commercial manufacture,GMP certificate is mandatory required,and qualification and validation are the very key components of GMP quality management,facility utility and equipment must be verified with scientific qualification and validation approach to meet all the requirements.This assay firstly describe how to create the qualification and validation master plan including the organization chart,responsibilities for relevant persons and the basic approach and method of qualification and validation.Secondly it mainly focuses on the qualification and validation method for critical systems based on risk approach,and put forward the proposal of qualification and validation for those systems.