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Draft 6. Note: This document is a draft suggestion only and is not an approved document.
Please do not distribute to laboratory staff for use.
Appendix D: Pharmaceutical Analysis and Legal Standards
(A pharmaceutical laboratory approach to measurement uncertainty is stated in ISO/IEC 17025 Sections. 5.4.1,
5.4.6.2, 5.4.6.3, 5.6.3.1, and 5.6.3.2)
A pharmaceutical product shall conform to its Legal Standard Requirements throughout its expiry period. The Legal
Standard Requirements include an allowable statement of uncertainty. Uncertainty or variance components resulting
from sampling, Legal Reference Methods (testing requirements), Compendial Reference Standards, etc., are included
in the Legal Standard Requirements. It is very important that the Compendial Reference Standards values and the
assessments of Legal Standard Requirements remain unchanged because these values are linked to the product safety
and efficacy data. Any uncompensated change in a method or a Reference Material is a change in the Legal Standard
that should not occur without careful consideration with regard to manufacturing requirements, product safety and
efficacy implications, and market competition.
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