FDA released a guidance for industry entitled “Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers.”  This guidance is intended to provide clarification to the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance document “Q11 Development and Manufacture of Drug Substances” to improve harmonization and promote convergence for information that should be provided in marketing authorization applications and Master

Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM542176.pdf