NITROSAMINES
FDA Issues Final Guidance For Control Of Nitrosamine Impurities In Human Drugs
On Wednesday, September 4, 2024, the FDA released its final guidance for industry titled “Control of Nitrosamine Impurities in Human Drugs.” This guidance updates the previous version issued on February 24, 2021. It outlines two main types of nitrosamine impurities: small-molecule nitrosamine impurities, which are structurally distinct from the active pharmaceutical ingredient (API), and nitrosamine drug substance-related impurities (NDSRIs), which are structurally similar to the API and are typically specific to each API. The guidance addresses potential sources of nitrosamine impurities, methods for detecting them, and offers recommendations for risk assessments, testing, and implementing controls to prevent or minimize their presence in APIs and drug products. It also includes suggestions for an alternative bioequivalence approach for manufacturers and applicants who choose to reformulate their products to address nitrosamine impurities.
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Since 1992 Quantum Analytics Group has been supporting cosmetics and beauty product manufactures with testing and consulting services. Our services include consulting on cGMP standards and practices, product testing services to support quality and release testing, label reviews, quality audit support, and more.
QUANTUM Analytics Group Solves Problems. Our approach is to work closely with each client collaboratively, handling every project with personal care, and giving every client one-on-one attention. Then, through this collaborative approach, and our unique blend of experience and expertise, we focus on providing accurate, efficient and consistent data and results to address and resolve questions and issues that impact your products.
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DOWNLOAD THE GUIDANCE HERE:
First MoCRA Warning Letter
FDA Issues First MoCRA Warning Letter
The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents a significant shift in how cosmetics are regulated in the United States. On June 12, 2024, the FDA issued a warning letter to Landy International, a pharmaceutical manufacturer with products that fall under the cosmetics category. The letter highlighted violations of Current Good Manufacturing Practice (CGMP) regulations and emphasized that MoCRA applies to Landy International’s cosmetic products. This incident serves as an important reminder for the entire cosmetics industry about the critical need to comply with MoCRA.
The FDA Warning letter, which essentially addresses CGMP violations related to Landy International's drug manufacturing, mentions MoCRA, which is particularly significant. It highlights the fact that even companies not exclusively focused on cosmetics must understand MoCRA's regulations if their products qualify as "cosmetic products" under FDA’s definition. The definition, found in 21 U.S.C. § 364(2) , defines a cosmetic product as "a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product". The definition covers a wide array of products, such as makeup, skincare, lotions, and shampoos, commonly found in the health and beauty sections.
Consequently, the Landy case serves as a warning for the cosmetics industry, emphasizing the need for proactive compliance with MoCRA to prevent regulatory issues, which may end up with a Warning Letter. MoCRA introduces a new phase in cosmetics regulation. By staying informed and ensuring compliance, companies can better secure their success in the constantly changing beauty market.
READ THE FDA WARNING LETTER:
