Identification of dietary ingredients is not just a critical part of Good Manufacturing Practices. In fact, identity is the only quality test which is required by FDA to be performed on all ingredients. However, identity testing is not ‘one-method-fits-all’; each ingredient requires an individualized review to determine suitable method.
IDDI Verification provides the following Quality Benefits in support of meeting GMP requirements for dietary ingredients:
1. An extra layer of assurance that appropriate test methods, specifications and supplier qualification methods are being used to determine the identity and quality of dietary ingredients and meet FDA requirements.
2. Clear recommendations on a specific testing and auditing plan, including methods and reference materials that are appropriate to use, which will support specifications and speed time to market.
3. Troubleshooting support and quality investigation of unexpected lab results, and recommendations to determine identity and quality of an ingredient conclusively.
4. A universal standard that can help align methods across different suppliers and laboratories, saving on the cost and complexity of retesting, duplication of efforts and failing test results.
5. An independent review panel of ID methods, product specifications and supplier information that can offer increased credibility over those from internal or contract laboratories.
6. Additional technical support to include analytical testing, addressing gaps in documentation, communications with labs regarding method alignment and troubleshooting unexpected test results on an as- needed basis.