Gap Analysis for Chinese Drug Control Institutes to Achieve the Standards of World Health Organization Medicine Prequalification.
The study aims to explore the challenges and the gaps faced by Chinese Drug Control Institutes in achieving the standards of World Health Organization (WHO) Medicine Prequalification. The study was undertaken with 6 Provincial Drug Control Institutes in China from November 2012 to November 2013. The study assessed key elements required to comply with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). For GPPQCL, the study found gaps in quality management system, control of documentation, data-processing equipment, premises and equipment, contracts, reagents (water), reference substances and reference materials, calibration, verification of performance and qualification of equipment, instruments and other devices, analytical worksheet, evaluation of test results, personnel, and validation of analytical procedures. The study indicates that gaps are attributed to differences between the standards of Chinese Accreditation Standards and WHO-GPPQCL.
College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China; Department of Quality Management, National Institutes for Food and Drug Control, Beijing, China.
Xin
X
Mao
College of Business Administration, Shenyang Pharmaceutical University, Shenyang, China. Electronic address: yyue315@126.com.
Yue
Y
Yang
D002138:Calibration; D002681:China; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D004335:Drug and Narcotic Control / Q000379:methods; D007202:Indicators and Reagents; D007391:International Cooperation; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D014944:World Health Organization
D007202:Indicators and Reagents
Chinese Drug Control Institutes; WHO Good Practices for Pharmaceutical Quality Control Laboratories; WHO Medicine Prequalification Program