Impact of data integrity on GMP inspection of Chinese pharmaceutical manufacturers
ZHANG Tie-jun
HAN Wen-tao
HAN Jing
Abstract：Data integrity deficiencies found during the GMP inspection process by EDQM,WHO,FDA and CFDA for the pharmaceutical manufacturers attracted great attention.Data integrity is a basic requirement of quality system and GMP.Chinese pharmaceutical manufacturers have to strengthen the quality awareness,promote the quality management level,and improve the quality management system to dissolve the data integrity deficiencies fundamentally and finally pass the GMP inspection.In this article,the authors analyzed the impact of data integrity on GMP inspection of Chinese pharmaceutical manufacturers from the above-mentioned aspects.
Keywords：data integrityGMPChinese pharmaceutical manufacturersquality system
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 985-989 )