CEI-MS-15 — worked example

§6Worked example

§6.1Worked example — why report-to-batch matching decides what a report can support

1. A supplier publishes 388 third-party reports. An assessor samples 60 and attempts to match each to a batch code on material obtained through the ordinary supply route.
2. 41 of 60 match a specific batch. 19 carry either no batch code or a code that does not correspond to any code observed on a container.
3. The 41 matched reports support statements about the batches they name. Each is a data point about a specific quantity of material.
4. The 19 unmatched reports support a different and much weaker statement: that testing occurred. They cannot support any claim about material a purchaser receives, because there is no way to establish whether the material tested and the material received have any relationship.
5. Extrapolating from 388 reports to "this supplier’s material is tested" therefore requires an assumption the reports themselves do not license. The Institute records the matched count and the unmatched count separately for this reason, and places only the matched reports in the verified column.

§6.2Illustrative mass balance

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
2. United States Pharmacopeial Convention. General Chapter ⟨1225⟩ Validation of Compendial Procedures. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.