GMP Problems
The FDA has issued a number of warning letters FDA issued Warning Letters for GMP violations of the Dietary Supplement Health and Education Act, where they cited failures of the firm’s supplier and vendor certification programs. They issued one to Global Sweet Polyols, LLC, a dietary supplement manufacturer, when they found the firm had failed to provide sufficient assurance that products received from a supplier were adequately identified and consistent with their purchase order. Another firm (Nuvonyx ) failed to qualify suppliers of components other than dietary ingredients. They did not establish the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examinations. A third firm (Nutro Laboratories) did not establish the reliability of the supplier’s COA for raw materials tests such as pH, Water-soluble substances, Residue on Ignition, and Assay.
Why vendor qualification is important:
Qualifying vendors is necessary in order to ensure the quality and identity of the materials received. A well-functioning vendor qualification program can significantly reduce the testing that must be done on incoming materials. It also reduces the risk of a final product becoming contaminated or adulterated. The FDA is conducting more inspections of dietary supplement manufacturers and packagers, and they expect a higher compliance rate in the future.
How to improve:
The first step is to establish a Vendor Verification program. This program should include:
- Qualification of all suppliers, including components, ingredients, labels, etc.
- Audits of suppliers and vendors
- Checking that COAs from vendors include specifications for identity, description, limits on contaminants, results, strength, and acceptance limits.
- Confirming the test results of certificates of analysis
- Re-qualifying the vendor at periodic intervals
- Reviewing specifications, procedures, and lab controls
- Regular reviews of vendor’s documentation
Conduct an audit of dietary ingredients and other component suppliers before accepting their COAs as primary documentation for compliance. An audit plan can consist of the following items:
- Agenda – list items you expect to review during the audit – for example, Current Organizational Charts, previous FDA/Regulatory Inspections, EIRs, FDA-483s, Warning Letters, etc.
- Documents Requested Prior to Audit – List any documents you would like the audit site to send prior to the audit.
- Organizational structure – clearly defines the line of authority and responsibility for quality.
- Facilities – inspect all areas to determine if they are well-designed, organized, and clean. Equipment must be maintained and environmental controls employed.
- Quality Systems – records of all inspections, evaluations, and validations should be analyzed.
- Documentation Control and Record Keeping – evaluate how control of documentation is done.
- Training/ Personnel – assess adherence to corporate policies and GMPs regarding cleanliness, garments, and personal habits.
Finally, remember that compliance can only be achieved through due diligence and ensuring that you are complying with the requirements you must fulfill in accepting materials from your dietary ingredient and component suppliers. InstantGMP™ has Standard Operating Procedures available for purchase that guide the vendor qualification.