Guidance for Industry on BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation." This guidance provides recommendations to holders of new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and drug master files or veterinary master files who intend, during the postapproval period, to change the site of manufacture, the scale of manufacture, the equipment, the specification(s), and/or the manufacturing process of intermediates in the synthetic pathway leading to the drug substance.