24/7 BIOPHARMA - issue 1 / October 2024

ALMAC SCIENCE

The author discusses the implications of the latest global update to the 18th edition of the Japanese Pharmacopeia (JP), which took effect on 1 July this year.

For pharmaceutical companies to sell their products in different markets, the materials used in those products must meet regional regulations. This poses a challenge for global companies with a global supply chain – as often, raw materials purchased in one country may not meet the regulations to be used in another. The pharmaceutical industry has undergone rapid reform in the analysis of elemental impurities in the past decade, including the most up-to-date technology that meets changing requirements in regulation. Elemental impurities are extractable elements that may be found in drug products, raw materials, drug substances or even excipients. They may be endogenous, added during the manufacturing process as a catalyst, or as an impurity through interactions with processing equipment. These elements need to be controlled as they do not provide any therapeutic benefit and can be toxic to the patient. The latest global update concerns the Japanese market – the 18 th edition of the Japanese Pharmacopeia (JP), which took effect on 1 July, 2024.

This update is significant because it brings the JP in line with the United States Pharmacopeia (USP). As this landscape continues to evolve, what does the future look like for international harmonisation and how can sponsors stay ahead of changing regulations? Historically, elemental impurities were assessed individually through a variety of wet chemistry techniques – many of which were antiquated and had been in use for over 100 years. Wet chemistry testing lacks specificity and accuracy, and the limits achievable by these older techniques lack sufficient sensitivity to meet the new limits being issued. In 2018, the USP took the action to lead the co ordination of pharmacopeia for international harmonisation of elemental impurity testing in pharmaceutical drug products. This resulted in the issue of chapter USP <233>. Comments were taken from both the European Pharmacopoeia (EP) and JP, which harmonised the testing of elemental impurities globally at the stage and time .

In 2020, the USP, together with the International Conference on Harmonisation of Technical

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TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024