의약품의 국제적 품질 경쟁력 확보를 위한 의약품실사상호협력기구(PIC/S)와한국의 GMP 비교연구

Abstract

It’s been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. ‘New GMP’ in 2008 has adopted validation,pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical InspectionCooperation Scheme) application by Korea’s Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunityto level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzingthe differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticalsand medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredientsand investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall betaken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (QualityRisk Management) and Q10 (Pharmaceutical Quality System).