world's leading manufacturer of pharmaceutical glass , proposed that the United States Pharmacopoeia reconsider the revision of pharmaceutical glass standards. The original text of the published article "Rethinking pharma ceutical glass standards: the need for dedicated testing strategies"
is
USP (USP) has proposed an amendment to General Rule < 660 > Containers-Glass is revised to provide specifications for glass containers used in the pharmaceutical industry. These changes are intended to modernize the tests and test methods along with the specifications in the chapter. The basic goal is to create additional flexibility for packaging and storage requirements. However, many experts in the pharmaceutical industry believe that this is a short-sighted move. Importance
of Pharmacopoeia and Quality Standards The key purpose of a pharmacopoeia is to establish minimum quality standards to ensure that materials used in the primary packaging of pharmaceutical products meet these standards. Glass containers tested for injectable pharmaceutical products should state the characteristics of the material, its intended use, and ease of handling to avoid misinterpretation of test results. Historical development
of USP testing Historical development of USP testing, specifically designed and customized for testing borosilicate and soda-lime glass, optimized over decades. However, this does not automatically mean that they are suitable for testing other glass types. Type I borosilicate glass is particularly suitable for chemically demanding pharmaceutical products because of its well-known resistance to hydrolysis. It minimizes the risk of negative interactions occurring before the expiration date of the stored drug product. Future
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pharmaceutical products and container solutions Because the future of new pharmaceutical products includes complex organic compounds such as biologics, gene therapy, and mRNA-based vaccines, novel container solutions must be developed to ensure that active properties are maintained throughout the product shelf life. This requires creativity and scientific understanding to adapt existing materials and develop new materials to accommodate liquid medicines. The challenge
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expanding the Class I classification is simply to expand USP < 660 > by applying a given test procedure to new container materials without understanding their advantages and disadvantages in relation to related pharmaceutical products. The acceptance of the Class I classification is a short-sighted move. It is critical to investigate key interaction mechanisms with pharmaceutical products based on leaching behavior, such as the interaction of refining agents or leached alkaline materials, particle nucleation and growth, and API degradation at the inner vessel surface. Harmonization of Global Standards and Expert-Based Approach
Modifications USP has less stringent requirements for new container materials, which contradicts the global approach of harmonizing drug product requirements based on container solutions from national pharmacopoeias. The USP revision approach ignores the expert-based approaches of organizations such as ICH, PDA, and ISO, which define comprehensive guidelines for pharmaceutical applications and related topics and provide only quick fixes for short-term political goals. Implications
for startups and think tanks While established pharmaceutical companies may have data to understand the risks and challenges of new container materials, startups and think tanks may overlook the interaction of drugs with containers over their shelf life, potentially facing unexpected performance issues over the expected shelf life of the product. Recommendation
for USP Reconsideration USP is strongly advised to reconsider its decision and add new glass compositions as new types, including specialized testing strategies, to ensure the quality and safety of drugs and their containment solutions for the benefit of patients worldwide.
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