Comparative Study of General Notices in Pharmacopoeias in Japan, the United States, and Europe

Abstract

Globalization of pharmaceutical supply chains has expanded and manufacturers are required to manufacture products in compliance with the pharmacopoeial standards used in all exporting countries/regions to ensure product quality. International harmonization has been facilitated by the Pharmacopoeial Discussion Group consisting of the Japanese Pharmacopoeia, the United States Pharmacopeia, and the European Pharmacopoeia. However, since the pharmacopoeias have been developed individually under the regulatory framework of each country/region, differences exist between these pharmacopoeias. When using pharmacopoeias, an understanding of common pharmacopoeial rules is essential. Clarifying the similarities and differences in the General Notices of the pharmacopoeias widely referenced worldwide is considered valuable for those already using one or two of them to access the remaining pharmacopoeias. In this study, we compared the existence of items and the contents described in the General Notices of the three pharmacopoeias to clarify the differences. Investigation of the existence of items revealed that more than 70% of the 105 items in General Notices in the three pharmacopoeias were in the entire pharmacopoeias (for Japan, including Japanese laws and notifications). Furthermore, investigating contents revealed that approximately 20% of the 105 items have some differences such as numerical values and test conditions. However, it was shown that most of the items did not have major differences. It is expected that the three pharmacopoeias will be utilized simultaneously by understanding the similarities and differences shown in this study.

Effects of Granulated Lactose Characteristics and Lubricant Blending Conditions on Tablet Physical Properties in Direct Powder Compression

“…32,33) Relevance between the Mg-S Added Amount, Blending Time, and Tablet Properties The international harmonization of product quality is being promoted at the International Conference on Harmonization of Pharmaceutical Regulations in Japan, the United States, and Europe. 34) Subsequently, according to the concept of Quality by Design (QbD), it became necessary to incorporate the quality of formulations into products from the design stage. [35][36][37][38] In other words, rather than setting various individual process parameters, it is important in QbD to determine those that directly affect the quality target product profile of the final product.…”