Reviewed and Approved by Shelly Blackwell, Senior Director of Dietary Supplements and Tobacco Services, EAS Consulting Group; and Tim Lombardo, Senior Director of Food Services, EAS Consulting Group
1-Minute Summary
- FDA regulations require you to qualify your suppliers before relying on their Certificate of Analysis (COA).
- The Foreign Supplier Verification Program (FSVP) mostly does not apply if an imported dietary supplement component meets cGMPs under 21 CFR 111.
- A comprehensive Supplier Qualification Program should include written Standard Operating Procedures (SOPs), Supplier Questionnaires, and both desk and onsite audits.
- Periodic requalification of suppliers is mandated, depending on factors such as component risk and supplier performance over time.
- Procedures for supplier disqualification should be in place, based on criteria like poor performance, legal actions, or special cause events.
Supplier Qualification Guide for the Dietary Supplements Industry
Ensuring the quality of dietary supplements not only requires in-house quality control but also a robust supplier qualification process. With globalization, the range of supplier locations has broadened, increasing the importance of establishing stringent verification procedures, both domestically and internationally.
This guide outlines the regulatory requirements for supplier qualification, including foreign supplier verification, and details the steps involved, tailored specifically for quality personnel in the dietary supplements industry.
Why Supplier Qualification?
Let's start with the obvious question: Why supplier qualification in the first place?
It is crucial to carefully select suppliers for your manufacturing operations who adhere to the appropriate GMP standards. In the unfortunate event that something goes wrong, regulators won't accept you trying to shift blame onto your suppliers simply because you failed to qualify them.
Therefore, it is vital to ensure that your suppliers or contract manufacturers are the right partners for your business and comply with the necessary regulations to help protect your brand and the public.
What are the FDA Regulations for Supplier Qualification?
21 CFR 111 Subpart E: Sections 111.70, 111.73, and 111.75 require supplement manufacturers to establish component specifications for identity, purity, strength, composition, and limits of potential contaminants.
FDA stipulates that testing must be conducted to verify compliance with these specifications upon receipt of each shipment. (Discover all FDA dietary supplement testing requirements here.)
While the regulations allow you to rely on the supplier's Certificate of Analysis (COA) to ensure compliance with some component specifications, FDA clearly states you must...
- First qualify the supplier by establishing the supplier's CoA through confirmation testing.
- Maintain documentation of how you qualified the supplier.
- Periodically reconfirm the supplier's CoA.
- Have your quality control personnel review and approve the documentation, setting forth the basis for qualification (and re-qualification) of any supplier.
So, as FDA clearly states, you must qualify your suppliers if you plan to rely on their COA to justify reduced testing.
Does the Foreign Supplier Verification Program (FSVP) Apply to Dietary Supplements?
Most of the standard requirements of the Foreign Supplier Verification Program (FSVP) do not apply if an imported dietary supplement component (i.e. an ingredient) meets specifications established in accordance with dietary supplement Current Good Manufacturing Practices (cGMPs) issued in 21 CFR 111. However, there are modified requirements for dietary supplements and dietary supplement components.
According to 21 CFR 1 Subpart L: Section 1.511(a):
"If you are required to establish specifications for a food that is a dietary supplement or dietary supplement component, and you determine whether the specifications you established are met for such food, then for that food you must comply with the requirements in 1.503 and 1.509, but you are not required to comply with the requirements in 1.502, 1.504 through 1.508, or 1.510."
Let's look at the requirements of 1.503 and 1.509.
Requirements of 21 CFR 1.503 for Dietary Supplements
- Qualified Individual Requirement: A qualified individual must develop the FSVP and have the education, training, or experience necessary to perform their assigned activities.
- Qualified Auditor Requirement: A qualified auditor must have the technical expertise obtained through education, training, or experience to perform the auditing function.
Essentially, when drafting your Supplier Qualification Program, it is crucial that the Quality Unit consists of individuals who possess the appropriate education, experience, or training to develop these programs on your behalf.
Furthermore, if auditing is required, it is imperative that the individuals assigned to this function have the requisite training and experience to fulfill their responsibilities effectively.
Requirements of 21 CFR 1.509 for Dietary Supplements
The second requirement, 1.509, pertains to the U.S. customs and borders regulations for imported products.
- You must ensure that, for each line entry of food offered for importation into the United States, your name, email address, and unique facility identifier, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection.
- This U.S. agent or representative serves as the primary point of contact for the FDA regarding any questions, concerns, or other communications.
Steps in the Supplier Qualification Process
Let's delve into the essential steps for qualifying a supplier.
Step 1: Develop Written Standard Operating Procedures (SOPs)
You should have a written SOP that details your supplier qualification process. It should include...
- Steps taken for qualification and re-qualification.
- Required documentation (what documents are you going to gather, what documents are you going to create, and what documents are you going to keep on file?).
- Steps for ongoing monitoring to ensure qualified status.
- Approval by the Quality Unit.
Step 2: Develop a Supplier Questionnaire
Sending a Supplier Questionnaire to your suppliers and reviewing their feedback is a major component of an effective Supplier Qualification Program.
The objective is to gather sufficient information about the supplier to conduct an initial risk assessment of their quality management system and the components they supply. Design your questionnaire to assess the following information:
- Certificate of Analysis, specifications, and test methods used.
- The Supplier’s Quality Management System and Quality System SOPs.
- Manufacturing process details.
- Regulatory history (FDA inspection reports, enforcement reports, warning letters, recall lists, safety alerts, FTC actions, etc.).
- Third-party certifications.
It is important to note that while third-party certifications can be valuable, they should not be the sole factor in determining a supplier's qualification status. These certifications should be one aspect among others that are evaluated to ensure a comprehensive assessment is conducted.
Pro Tip: Don't include simple yes/no questions on your Supplier Questionnaire. Ask for a detailed description of their processes so you can make a thorough assessment. Request their SOPs so you can review them.
Step 3: Perform a Risk Assessment (Desk Audit)
An initial risk assessment using risk management principles can be performed based on the type of ingredient and supplier. For example, an ingredient that is subject to economic adulteration may have a higher risk than a synthetic Vitamin. Additionally, a supplier in a country with low regulatory oversight may have a higher risk rating.
The next step is to review the Supplier Questionnaire. The objective is to assess the supplier's Quality Management System and to determine compliance with applicable cGMPs and other standards.
This step helps to justify reliance on the supplier's Certificate of Analysis. Some basic elements of their Quality Management System should include:
- Management oversight of quality
- Facility and equipment operating systems
- Material management systems
- Production and control systems
- Packaging and labeling systems
- Laboratory control systems
Step 4: Perform an Onsite Audit (if Needed)
While a desk audit can be done as an alternative to an onsite audit, it does not provide the same level of detail. Onsite audits are preferred as they allow for a comprehensive assessment of the supplier's facilities and processes, and should be required for high risk suppliers.
Audits can be performed by...
- The component customer
- Independent third-party certification body
- Independent third-party auditor
Step 5: Conduct COA Confirmation Testing
Many manufacturers have the goal of reduced testing (besides identity testing, which must be done on every lot) to save time and money.
But, as said earlier, the regulations in 21 CFR 111.75 clearly state that you must qualify your supplier before relying on their COA, which involves verifying the reliability of the test results they provide.
Ensure their COA includes the following minimum required information:
- Test results
- Specifications limits
- Methods used for testing
Conduct your own testing at a qualified dietary supplements testing laboratory to confirm the supplier's COA and include that documentation with your recordkeeping.
The scope, number of samples, and frequency of confirmation testing depend on the risk associated with the component and the supplier. It is important to consider different risk levels and establish specific frequencies for testing accordingly. This ensures comprehensive quality control measures are in place.
Step 6: Periodic Requalification
Regulations require you to periodically re-qualify your suppliers and their Certificate of Analysis if you rely on it for reduced testing. It's important to note that you're not just reconfirming the supplier's COA, you're again going through the entire qualification process for each supplier.
The main question people have is, How often do I re-qualify a supplier? The scope and frequency of re-qualification depends on...
- Risk posed by the component.
- Supplier's performance over time.
- Number of batches sourced from the supplier over a given period.
Naturally, a supplier with a higher risk level compared to a lower-risk supplier would require different frequencies for requalification or COA confirmation. These parameters should be defined within your Supplier Qualification Program.
Step 7: Supplier Performance Monitoring & Disqualification
The final piece for supplier qualification is your procedures for determining if you need to disqualify a supplier. Some potential criteria for disqualification may include the following:
- Poor supplier performance (cGMP audit observations, failed COA confirmation tests).
- Legal or regulatory actions (consent decrees, warning letters, criminal prosecution).
- Special cause events (adulterated or misbranded products).
Get Help Developing Your Supplier Qualification Program
An effective Supplier Qualification Program is a fundamental requirement for quality control in the supplements industry. It ensures that suppliers are reliable, adhere to regulations, and can consistently deliver products that meet your standards.
Developing and implementing such a program can be challenging and time-consuming. If you need assistance in crafting a comprehensive Supplier Qualification Program tailored to your needs, contact our regulatory partners at EAS Consulting Group.
