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Are You Ready to Implement Your Distributor GMP Playbook?
We are a virtual consulting company specializing in helping Distributors be GMP compliant.
Brand Owners / Distributors
If you own a brand in the dietary supplements or cosmetic industry and outsource all your services (manufacturing and/or distribution), you are 100% responsible for ALL GMP compliance. We offer a flat-rate fee to implement GMP systems that are required for you to be compliant. Give us a month and we will give you a GMP Playbook which includes Word versions of SOPs, forms and a Quality Agreement template.
FDA Warning Letters
"Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce is not adulterated for failure to comply with dietary supplement CGMP requirements."
"As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to
approve and release the products for distribution."
GMP Playbook's frequently asked questions
FAQ
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:
- Final approval and release of every product lot for distribution to customers for sale (this task cannot be delegated).
- Reviewing and approving all finished product specifications and controls that may affect identity, purity, strength, or composition.
- Investigating product complaints and preparing the final reports.
11. On what basis must the Distributor Quality Unit approve and release each product lot for final distribution?
Answer: The Quality unit must approve the product based on a review of documentation that includes (but is not limited to): the CMO’s COA, a formal product lot approval document (Lot Disposition Checklist), the Distributor’s receipt and inspection report, and the formal, written documentation of the Distributor’s quality unit approval decision. Merely relying on an approved COA is insufficient.
12. What specific requirements govern the handling of product complaints?
Answer: You must establish and follow written procedures for handling complaints. This includes maintaining a written record (Complaint Log) of every complaint related to good manufacturing practice, including the product name, lot number, date received, nature of the complaint, and investigation findings. A qualified person must review and investigate any complaint that involves a possible failure to meet specifications or a risk of illness or injury.
13. What is the required timeline for reporting Serious Adverse Events (SAEs) to the FDA?
Answer: If a serious adverse event occurs, the Distributor must report it to the FDA within 15 days of becoming aware.
14. What are the legal requirements for collecting and holding reserve product samples?
Answer: Reserve samples must be collected and held for each lot of packaged and labeled dietary supplement distributed. They must be retained for 1 year past the shelf life date (if used) or for 2 years from the date of distribution of the last batch associated with the reserve sample (if no shelf-life dating is used). They must be stored using the same container/closure system in which the product is distributed.
15. What activities can cause a dietary supplement product to be cited as an “unapproved new drug” or "misbranded"?
Answer: Marketing the product with disease-related claims renders the product an unapproved new drug. FDA inspectors frequently review labels, website content, promotional materials, and marketing material during inspections, which often leads to observations that the product is misbranded or described as a new drug.
About GMP Playbook
GMP Playbook is a dedicated virtual consulting company that offers brand owners/distributors quick and easy GMP compliance solutions to help their small to medium-sized businesses comply with FDA regulations. Our team of experts has extensive experience in GMP compliance for dietary supplements and cosmetics. We pride ourselves on our commitment to quality, and we work closely with our clients to implement a complete GMP Playbook within a month.
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