Residual Solvents in GMP: Classes, Guidelines and Testing
Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP.
Defining Specification Limits for Impurities in New Drug Products
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.
Impurities in Pharmaceuticals: Types, Regulations and Strategies
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…
FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products
Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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.