Research And Analysis Of Chinese Medical Product GMP Validation

Objective:The GMP is the abbreviation of the good manufacturing practices for medical products.And the GMP is the implementation of legal and scientific and standardized management of the specific requirements of this particular article of drug and related products.It’s the quality guarantee system applying to medical industry. The GMP validation is anintegral part of GMP. It’s a series of activities with document certificate of bearing out any procedure, equipment, material, activity or system certainly leading to expected result. At present, although medical industry rule of our country has made provisionsin written that GMP validation should be carried out according to GMP’s requirement.But considering the situation of exportation for medical products, therefore existing Chinese GMP validation system can not archive current requirement for U.S or E.U marketing. This paper aims to this on the research and analysis of Chinese medical products GMP validation by advanced systems and high-quality GMP validation process, improve the safety and quality of medical products in China. Finally, finding a right way for Chinese medical product exportation.Methods:Though content, significance, specific practices and organization of GMP validation to get the importance of medical products GMP validation. Detially descript two aspects of validation:1. Throughout the life cycle of medical products in the validation loop (Prospective Validation, Retrospective Validation, Revalidation Validation).2. Throughtout validation process (Design Qulification, Installation Qualification, Operational Qualification, Performance Qualification and Products Qualification)3. Validation Organization and Document Requirement.And according to GE pharmaceutical company’s project to elaborate on the each of main points of validation step and acceptance crierion with company management theory, the final data obtained from statistical processing and filing into market to apply for the U.S. Drug and Food Administation Bureau.Conclusions:According to GE healthcare USB project with succefully entrancing into FDA, and Chinese existing GMP validation procedure. Author summarizes a new19steps GMP validation procedure with Chinese style. Most important-advanced GMP validation will improve Chinese quality of medical products. And finding a right way for Chinese medical product exportation.