Drug product development: a technical review of chemistry, manufacturing, and controls information for the support of pharmaceutical compound licensing activities.

Due diligence is a vital activity in the acquisition or the in-licensing of pharmaceutical compounds for market commercialization. Pharmaceutical product due diligence is a detailed investigation of the chemistry, manufacturing, and controls (CMC) information associated with a drug product. The investigation provides assurance that a given compound will meet the requisite technical and quality elements to allow for successful commercialization of the drug product. This document provides an overview of the CMC information that is reviewed as part of the drug product due diligence activities. This review follows the format of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Module 3, Quality, of the ICH Harmonised Tripartite Guideline with some sections of the CTD template combined to simplify the presentation. A drug substance overview is given elsewhere.