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
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.
