2019 Kombucha ERP - Review Book

Does the method perform according to the method"s applicability as written? If No, please explain why the method did not perform according to the method"s applicability as written.

The method appears to perform well; however, the low number of MLV participants could miss identifying issues.

2. SAFETY CONCERNS

3. STATISTICAL REVIEW

4. REFERENCE MATERIALS

5. SINGLE LABORATORY VALIDATION

6. REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION

7. FINAL ACTION REQUIREMENTS

8. RECOMMENDED CHANGES (If any)

Are there any recommended changes to the AOAC First Action method as written?

1) AOAC 2016.12 in OMA includes excerpts from the SLV and contains specific instrument supplier names & brands, and does not state equivalent instruments or columns can be used. OMA methods must focus on scientific parameters and avoid product endorsements unless the products are unique. 2) I am concerned with only 4 participants in the MLV study. This low participation could miss potential method issues.

9. END USER FEEDBACK:

Document positive and negative feedback from users of the method during the trial period. Feedback from users demonstrating method ruggedness should be documented. Assess the future availability of vital equipment, reference materials, and supplies.

FINAL ACTION RECOMMENDATION

Do you recommend this method be adopted as a Final Action Official Method of Analysis and published by AOAC INTERNATIONAL? Please specify rationale for your answer.

Reccomend repeating MLV syudy.