Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outsi...Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outside markets such as Europe.This means that the majority of companies producing medicinal products to higher regulatory standards have less international experience/exposure in handling the GMP requirements demanded by PIC/s[1].In addition most of their processes are manual with legacy practices,and mostly the data and controls are in paper with a very high amount of data made with pen and paper on numerous human reviews of documentation mainly to assess the data is complete but not for accuracy of the data at the time that action could be taken—data integrity on paper has been shownto be highly questionable.展开更多
Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Qu...Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and efficiently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM),Supplier Management and Audit Management.By operating a paper QMS.展开更多
文摘Today the ASEAN Pharmaceutical manufacturing companies are still focusing on their local countries,with the exception of a fewlarge regionals who are already and increasingly looking and capable to export to the outside markets such as Europe.This means that the majority of companies producing medicinal products to higher regulatory standards have less international experience/exposure in handling the GMP requirements demanded by PIC/s[1].In addition most of their processes are manual with legacy practices,and mostly the data and controls are in paper with a very high amount of data made with pen and paper on numerous human reviews of documentation mainly to assess the data is complete but not for accuracy of the data at the time that action could be taken—data integrity on paper has been shownto be highly questionable.
文摘Compliance to the PIC/s GMP[1]standards is a mandatory and challenging requirement for ASEAN Pharmaceutical manufactures.PIC/s has at its foundation and as a very strong basis the need for a robust and wide ranging Quality Management System that will impact nearly all the departments in the organization and requires companies to setup detailed controls and records across all relevant quality aspects.To achieve the PIC/s quality objectives reliably and efficiently,a comprehensively designed and implemented QMS will be based on the Quality Assurance principles and will integrate GMP,Quality Control and Quality Risk Management.The key functions required in a QMS are Document Control,Training Management Quality Event Management Quality Risk Management(QRM),Supplier Management and Audit Management.By operating a paper QMS.
