The U.S. Food and Drug Administration (FDA) has issued a Guidance document addressing supply-chain programme requirements and co-manufacturer supplier approval and verification procedures for human and animal food.
Issued in November, the Guidance addresses specific FDA regulations applicable in co-manufacturing arrangements where potential hazards are identified that require a “supply-chain-applied control.” Co-manufacturing arrangements are those in which a brand owner specifies to its manufacturing partners those suppliers that must be used.
Guidance documents issued by the FDA and other U.S. government agencies are intended to present the current thinking of a regulatory agency on specific topics, do not establish legally enforceable responsibilities, and are not binding on either the FDA or the public. Nonetheless, they can be helpful in developing policies and procedures that support compliance with FDA regulations and requirements.
The complete text of the FDA’s Guidance on supply chain programme requirements is available here.