Analysis of Deviation Management-Related Deficiencies in WHO On-Site Inspections of Pharmaceutical Manufacturers in China
This study aims to analyze the deficiencies related to deviation management identified in on-site inspection of China's pharmaceutical manufacturers by the WHO,and determine the causes of these deficiencies.Strategies and recommendations are proposed to address the identified issues.This paper reviews WHO's publicly available inspection information,and summarizes the proportions,severity,and specific problems related to deficiencies related to deviation management.A total of 13 deficiencies related to deviation management were identified,accounting for 3.35%.All these deficiencies were classified as major,with main issues including insufficient investigation and evaluation,unreasonable grading of deviations related to product production,and inappropriate corrective and preventive measures.Inadequate operator training led to ineffective identification,reporting,and handling of deviations.Weak management of deviation processing records and attachments,along with imperfect deviation management documentation is not perfect,were also observed.Recommendations include the establishment of a cross-functional expert team for comprehensive investigation and evaluation of production deviations using root cause analysis tools.There is also a need to create a database for deviation handling cases,conduct continuous training and assessment,and refine requirements for record management,trend analysis,and repeated deviation handling.
万方数据
维普
