Hello Food Safety Professionals,
I am new to dietary supplements and I have a non conformance from our audit because of this requirement (Posted below). I have explained to the auditor that we do testing for identity every time a new supplier is going to be approve. However, the are insistent that we need to test every batch. We are a small company and to test every batch is 350 dollar per ingredient. Also, I read to the auditor that it says it is only for dietary ingredients, but she insistent that it has to be for all ingredients that are aim to produce the dietary supplement.
Can you give me any idea on how you comply with this requirement or how do i get an exemption, if somebody have apply to that. Very much appreciated.
§ 111.75 What must you do to determine whether specifications are met?
(a) Before you use a component, you must:
(1)
(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing;
(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under § 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and
(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with § 111.70(b) are met. To do so, you must either:
(i) Conduct appropriate tests or examinations; or
(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that:
(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations;
(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;
(C) You maintain documentation of how you qualified the supplier;
(D) You periodically re-confirm the supplier's certificate of analysis; and
(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
