| With the increasingly high degree of automation and informatization of the equipments in pharmaceutical industry,the computerized system provides enterprisesa better operation guarantee,and also improves the production efficiency and yield rate.Therefore,the compliance of computerized systems in the quality of pharmaceutical production has become an important requirement of GMP regulations.GMP is the mandatory requirement of national drug regulatory agency for standardization of personnel,plant facilities,equipment,materials,management system and other aspects of pharmaceutical enterprises.It is the minimum requirement for pharmaceutical production and quality management.The validation compliance of the computerized system can prove that the system can meet requirements and consistent operation to ensure the reliability of the system and the stability of product quality.This paper analyzes the problems existing in the validation management of computerized systems in pharmaceutical companies in China,especially the compliance and data reliability problems of legacy systems that enterprises have used before the formal implementation of GMP Appendix 11 Computerized Systems.Based on the risk assessment,the gap analysis is proposed to verify the new ideas of the legacy system,according to relevant domestic GMP and the validation requirements of the Good Automated Manufacturing Practice-Rev5(GAMP5)of the International Society for Pharmaceutical Engineering(ISPE).That is,to find the gap of the legacy system,the impact on patient safety,drug quality,data reliability,and finally to resolve the gap based on the level of risk.Meanwhile,combined with the author’s practical project “Online particle monitoring system validation of A company” to explain how to carry out computerized system validation of the enterprise’s legacy system.This article will provide reference for the compliance of the legacy systems of domestic pharmaceutical companies. |
PDF Full Text Request