FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited availability of disposable manufacturing materials during periods of increased demand (e.g., public health emergencies or natural disasters). Limited availability of disposable manufacturing materials can affect sterile drugs and biological products. This guidance describes chemistry, manufacturing, and controls (CMC) post-approval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. Applicants should use science-based and risk-based principles, and current FDA guidances for industry, to determine the appropriate reporting category to communicate changes to disposable manufacturing materials.
This guidance applies to biologics license application (BLA) products; human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications (ANDAs); and animal drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs). This guidance also 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 [FDA]