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OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Appendix E: Dietary Supplement Laboratories

1. Validation of methods

 Dietary supplement analytical laboratories are facing unique challenges dealing with ever changing new formulations, ingredients, new matrices. Dietary supplement laboratories should ensure that their methods are adequate and “fit for purpose”. During the method validation it is preferable to work with well characterized, homogenized, and stable materials such as Certified Reference Materials (CRMs) and/or Standard Reference Materials (SRMs), hovewer the availability of CRMs and SRMs specific to dietary supplements is limited. CRMs and SRMs can be obtained from variety of sources, including, but not limited to NIST, US Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.), American Herbal Pharmacopoeia (AHP), and PhytoLab.  As appropriate PT programs are currently not available for the dietary supplement laboratories, the laboratory shall document in their plan its planned participation in interlaboratory comparisons. One of the recommended interlaboratory comparison/quality assurance program is the NIST established Health Assessment Measurements Quality Assurance Program (HAMQAP). Participants measure concentrations of nutritional and toxic elements, fat- and water-soluble vitamins, fatty acids, active and/or marker compounds, and contaminants in samples distributed by NIST. Participant data is compiled at NIST and analyzed for accuracy, precision, and concordance within the community.  When no interlaboratory comparison is available, the laboratory shall develop and justify an alternative plan for monitoring data. 2. Ensuring the validity of the results - Proficiency testing

3. Out of Specification investigation (OOS)

The following questions can be helpful when conducting OOS investigation and root cause analysis:

Section A: Operator -

Operator followed correct test method? Operator followed test method as written? Has operator trained on the procedure?

- -

Section B: Equipment -

Correct equipment used?

- Equipment examined and found to be functioning? - Equipment calibration is current?

Section C: Materials -

Were the samples handled, stored and prepared properly? - Correct standard(s) used? - Are standards within expiration date? - Were standard(s) and/or sample(s) prepared correctly? - Correct chemicals/reagents used according to test method? - Are chemicals/reagents used within expiration date? - Were chemicals/reagents (including buffers and solutions) prepared correctly?

Section D: Data -

Raw data properly and completely documented on appropriate controlled form? - Calculations performed properly?

08/09/2018