Consumers want to know the when, where and how their dietary supplements are produced. The FDA also requires supplement manufacturers to have a system in place for qualifying vendors. Properly qualifying vendors in accordance with Good Manufacturing Practices (GMPs) ensures the identity and the quality of the ingredients used in production, reduces the risk of contamination and ultimately saves money by reducing the amount of testing required on incoming materials. The vendor qualification process contributes to the overall quality of your product, ensuring consumer safety.
 
Establishing a Vendor Qualification Program
First and foremost, document exactly what materials (raw materials, ingredients, components, packaging and labels) will be used in production. Create a list of vendors and have your quality team establish specifications for each material that your vendors must meet. Choose reputable vendors that share in your commitment to quality. Every vendor qualification program should include:
 

• Qualification requirements for all vendors including suppliers of raw materials, components, ingredients packaging and labels;
• Audits of suppliers and vendors;
• Certificates of Analysis (COA) that include specifications on identity, critical characteristics, testing methods and results of testing;
• Test results that confirm the accuracy of the certificate of analysis;
• Schedule for re-qualifying vendors at periodic intervals;
• Schedule for reviewing specifications, standard operating procedures and lab controls;
• Schedule for reviewing vendor documentation.

 
Conducting An Audit
Once you’ve selected a vendor, or maybe two vendors so you have a back-up, the FDA requires that you complete an audit before you can accept their materials. For the dietary supplement industry, the FDA doesn’t require an in-person audit, but this extra step can certainly help, and may actually be easier considering the amount of information you are required to collect. Before you conduct the audit, establish an agenda and a list of items that you’d like to review, such as current organizational charts, previous regulator inspections and past FDA warning letters.
 
You can find a set of industry standard audit forms at http://gmpcertification.org/gmp-resources. Send the list to the vendor so they can prepare. You should examine the following during the audit:
 

• Organizational structure – Does the potential vendor have an in-house quality team? Who is in charge and what are their qualifications?
• Facilities – It is best to inspect the facilities in person. Check for environmental controls, overall cleanliness and maintenance of equipment, and flow of personnel and processes.
• Quality Systems – What quality systems do they have in place? Check their SOPs, quality manuals and records of inspections. Check that they follow their SOPs.
• Documentation control and record keeping – Do they have a paper system or an electronic system? More importantly, how organized are their records?
• Personnel – Is the staff properly trained and committed to quality? Check training records and assess knowledge of SOPs and Good Manufacturing Practices.

 
Testing
Initial deliveries of supplies from your qualified vendors must be tested in-house by your company or by a third party. Each component’s COA should include a description of the tests performed on the material, the methods used, the accepted range of results and the actual results. Testing methods should verify the identity, purity and potency of the component. If your test results match the vendor’s COA, the component can be released for production after the quality team signs off on it. You can accept the supplier’s COA without further in-house testing if your vendor qualification procedures specify how many lots are checked before the COAs can stand on their own.
 
Moving Forward with Consistent Quality
No matter how thorough your initial vendor qualification process is, producing high-quality, contaminant-free dietary supplements is an ongoing process. GMPs dictate that vendors should be re-qualified at regular intervals and COAs should be tested regularly as well. Establishing a schedule in your Standard Operating Procedures for this creates a loop for continuous quality and improvement. Maintaining open communication and sharing information with your vendors also strengthens the relationship. When consumers inquire about your ingredients, you can be confident that your vendors can be trusted.
 
Dr. Richard Soltero has more than 40 years of experience in the pharmaceutical industry. He is the founder of InstantGMP, which develops batch record software and SOPs that reinforce GMPs for the dietary supplement industry.