Articles QC Residual Solvents in GMP: Classes, Guidelines and Testing 6 March 2024 gmpinsiders Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP.
Articles QC Regulatory Defining Specification Limits for Impurities in New Drug Products 23 December 2023 gmpinsiders Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and quality compliance with ICH Q3B (R2) guidelines.
Articles QC Impurities in Pharmaceuticals: Types, Regulations and Strategies 17 December 2023 gmpinsiders Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements, testing strategies, and the importance of analytical methods in ensuring…
News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.
