1. What is the definition of a dietary supplement Distributor?
Answer: If your company contracts out services such as manufacturing, packaging, labeling, testing, and/or distribution, and the product is sold under your company’s name.
2. Who is ultimately responsible for cGMP compliance when manufacturing is entirely outsourced to a contract facility?
Answer: The product owner (the company whose name appears on the label) bears the "ultimate responsibility" for ensuring that all phases of production comply with dietary supplement cGMP requirements. A firm cannot contract out its ultimate responsibility to ensure the product is not adulterated due to failure to comply with cGMP requirements.
3. What is the obligation of the Distributor regarding the manufacturing activities performed by a Contract Manufacturing Organization (CMO)?
Answer: As the distributor, your firm has an obligation to know what and how manufacturing activities are performed. This knowledge is necessary so you can make decisions regarding whether products conform to established specifications and whether to approve and release the products for distribution.
4. Can a Distributor choose a CMO based solely on its reputation and cost?
Answer. A Distributor must first qualify the contract manufacturer.
5. What is required to qualify a CMO?
Answer: Qualification must include confirmation of the CMO’s registration with the FDA as a food facility. It should also involve requiring the CMO to complete a self-assessment qualification questionnaire (initially and annually), conducting an on-site facility audit (by the Distributor or a third party), and qualifying the Certificate of Analysis (COA) data. This process must be periodically re-qualified.
6. Is relying solely on a CMO’s Certificate of Analysis (COA) sufficient for incoming materials?
Answer: No, relying on a COA alone is necessary but insufficient. You must first qualify the supplier by establishing the reliability of the COA through confirmation of test results at appropriate intervals. If relying on a COA, you must maintain documentation of the qualification and re-qualification process, and the COA must include the method(s) used, limits, and actual results.
7. Is a formal Quality Agreement required by FDA regulation for dietary supplements?
Answer: A Quality Agreement is not a regulatory requirement for dietary supplements. However, it is strongly recommended to clearly establish the responsibilities of the Quality Unit and cGMP compliance for each party. FDA inspectors have begun asking if a Quality Agreement is in place during audits.
8. What critical documents must the Distributor originate, approve, or co-approve, regardless of outsourcing?
Answer: The Distributor must be the originator and primary approver of formulations, product specifications, and labeling for its products, particularly for raw material and primary packaging materials unique to those products. The Distributor must maintain copies of all MMRs, specifications, and approved formulas.
9. What is the most common cGMP violation cited by the FDA related to production controls?
Answer: The most common violation cited is the failure to establish specifications for the identity, purity, strength, composition of components, and/or finished dietary supplements. This issue stems partly from Distributors failing to provide their CMO’s with adequate specifications for the product they want made.
10. What are the key non-delegable responsibilities of the Distributor’s Quality Unit?
Answer: The Quality unit must establish written procedures for its responsibilities. Core duties include:
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