Reduction in Dissolution Test Results Variability of A/B Capsule Product

Abstract

Since the origins of the agency, the Food and Drugs Administration (FDA), a scientific, regulatory, and public health agency had been dedicated to consumer protection. The FDA, provides standardized regulations and guidance to pharmaceutical industry. Under the agency umbrella are covered different organizations: The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to the people. The CDER works in the publication of diverse guidance for industry that include, scale up and post approval changes (SUPAC), testing of immediate release (IR) and modified release (MR) dosage forms, and the Investigation of Out-ofSpecification (OOS) Test Results for Pharmaceutical Production. Any failure or violations on drug products is considered to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)]and the current Good Manufacturing Practices (cGMP). Considering this, a recognized failure in dissolution testing is considered adulteration of the drug product with negative consequences to the manufacturing facility. Key Terms — Dissolution, Failure, Guidance, Requirements.