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for the introduction and thanks to everyone attending this afternoons workshop sessions id like to share with you some of the key concepts surrounding the determination of impurity profile equivalence as it relates to fdas published draft guidance on post-approval changes to drug substances in september of 2018 fda published the draft guidance for industry entitled post-approval changes to drug substances its classified in the category of drugs and the subcategory of pharmaceutical quality cnc it focuses on changes to drug substance manufacturing during a drug product applications post-approval period it applies to holders of approved new drug and abbreviated new drug applications as well as new animal drug and abbreviated new animal drug applications and the holders of drug master files and veterinary master files who want to make a change to the drug substance manufacturing during the drug products post approval period specifically it addresses how the risk of one or more changes