위험관리 기법을 이용한 무균의약품 제조소 Contamination Control Strategy 수립 방안 연구

Manufacturers engaging in Good Manufacturing Practice (GMP) for a sterile product are required to establish aContamination Control Strategy (CCS) to prevent product contamination. Domestic and overseas regulations including the EUGMP Guideline “Annex.1 Manufacture of Sterile Products” mention the importance of establishing a CCS; however, despitementioning a risk management method, the Annex does not describe a specific implementation method. Sterile productmanufacturers should take measures to prevent product contamination by establishing an appropriate CCS. Therefore, thisstudy presents a method for establishing a CCS strategy, as required by various guidelines, using the quality risk managementmethod presented in ICH Guideline Q9. In this study, when establishing a CCS strategy by applying the quality riskmanagement method, it was possible to confirm factors affecting product contamination through Cause and Effect Analysis,and the degree to which each factor influences product contamination through Failure Mode and Effect Analysis. Based onthese results, when establishing product contamination countermeasures, manufacturers can identify the items requiringimprovement and evaluate the strength of these measures. Finally, the manufacturers can establish a CCS at the level requiredby the relevant guidelines. This study is meaningful in providing a method for establishing a CCS that can be applied bysterile product manufacturers in the future by presenting a CCS using the quality risk management method. KCI Citation Count: 0