ABSTRACT

The Food and Drug Administration’s (FDA) biologics regulations defi ne manufacturer as “any legal person or entity engaged in the manufacture of a product subject to license under the PHS Act,” including “any legal person or entity who is an applicant for a license where the applicant assumes responsibility for compliance with the applicable product and establishment standards” (21 Code of Federal Regulations (CFR) 600.3(t)). A manufacturer thus includes a license applicant, who may or may not own the facilities engaged in signifi cant manufacturing steps, when such an applicant assumes responsibility for compliance with the applicable product and establishment standards, including, but not limited to, 21 CFR Parts 210, 211, 600 through 680, and 820. Manufacture is defi ned as “all steps in propagation or manufacture and preparation of products and includes but is not limited to fi lling, testing, labeling, packaging, and storage by the manufacturer” (21 CFR 600.3(u)). A manufacturer of a biological product must demonstrate responsibility for the manufacturing process as described in its biologic licence application (BLA) (21 CFR 600.3(t)). For example, a manufacturer must avoid introduction of contaminants during production (21 CFR 610.13).