About this document
Quality Guidelines for Finished Products by Nayeli Mercado is a document available to read on EtoBox.
This document provides guidance for quality submissions related to finished pharmaceutical drug products. It outlines the key information to include in sections related to drug product description and composition, pharmaceutical development, and components of the drug product. Specifically, it indicates that the pharmaceutical development section should discuss studies establishing the suitability of the dosage form, formulation, manufacturing process, and container closure system. It also notes relevant IC
- Author
- Nayeli Mercado
- Language
- EN