This guidance describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. This guidance applies to biologics license application (BLA) products licensed under section 351(a) or 351(k) of the Public Health Service Act (PHS Act); human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications (ANDAs) under section 505(b)(1), 505(b)(2), or 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and animal drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) under section 512(b)(1) or 512(b)(2) of the FD&C Act. This guidance applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016).