This guidance provides recommendations to holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs) and holders of drug master files (DMFs) and veterinary master files (VMFs) who want to make a change to the drug substance manufacturing process during the drug product application’s postapproval period.
It does not address holders of biologics license applications (BLAs) or holders of any master files cross referenced in BLAs.
The guidance applies to synthetic drug substances and the synthetic steps involved in preparing semisynthetic drug substances. The guidance covers the following changes:
• Facility, scale, and equipment changes associated with all steps of drug substance
• Specification changes to starting materials, raw materials, intermediates, and the unfinished and final drug substance.
• Synthetic manufacturing process changes.
• Changes in the source of the drug substance.
• Changes to the container closure system for the drug substance.