ScholarWorks@동국대학교

초록

Glass containers for pharmaceuticals are widely used as primary packaging materials because of their chemical stability and other beneficial properties. However, interactions between the drug product and the container, which may be influenced by drug characteristics or lapses in quality control, can lead to delamination and precipitation, posing risks to patient safety. To mitigate these risks, national regulatory agencies regulate the quality of glass containers through pharmacopoeias, which are regularly updated to reflect current scientific advancements. This study aims to analyze the standards for pharmaceutical glass containers in the Korean Pharmacopoeia (KP), United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP), with a focus on their regulatory frameworks, including purpose, definitions, scope, principles, test methods, and acceptance criteria. The findings indicate that KP test methods were similar to those of the JP but differed from those of the USP and Ph. Eur. in sample preparation, procedure, and evaluation of chemical durability. Furthermore, the USP and Ph. Eur. implement a durability-based grading system and provide additional information on quality control issues, such as delamination, in their General Information chapters. Given the recent growth in the development of container-sensitive biopharmaceuticals, robust and evidence-based quality control is critical. Harmonizing with international standards and further advancing pharmaceutical glass container quality control systems will enhance public safety in medication use and the competitiveness of the pharmaceutical industry.

키워드