Study of Establishing a Contamination Control Strategy using a Quality Risk Management for Manufacture of Sterile Products

Abstract

Manufacturers engaging in Good Manufacturing Practice (GMP) for a sterile product are required to establish a Contamination Control Strategy (CCS) to prevent product contamination. Domestic and overseas regulations including the EU GMP Guideline “Annex.1 Manufacture of Sterile Products” mention the importance of establishing a CCS; however, despite mentioning a risk management method, the Annex does not describe a specific implementation method. Sterile product manufacturers should take measures to prevent product contamination by establishing an appropriate CCS. Therefore, this study presents a method for establishing a CCS strategy, as required by various guidelines, using the quality risk management method presented in ICH Guideline Q9. In this study, when establishing a CCS strategy by applying the quality risk management 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 on these results, when establishing product contamination countermeasures, manufacturers can identify the items requiring improvement and evaluate the strength of these measures. Finally, the manufacturers can establish a CCS at the level required by the relevant guidelines. This study is meaningful in providing a method for establishing a CCS that can be applied by sterile product manufacturers in the future by presenting a CCS using the quality risk management method.