CEI-MS-15 — Protocol for independent third-party verification of a supplied preparation
Protocol for independent third-party verification of a supplied preparation
§1Scope
§1.1Scope
Applies where a preparation is to be independently verified by a laboratory that has no commercial relationship with the supplier. Defines the chain-of-custody, blinding and reporting requirements that make an independent result interpretable.
§2Principle
An independent result is only as good as the assurance that the sample tested is the sample supplied. Chain of custody, sample identity blinding and direct laboratory-to-requester reporting are what distinguish a verification from a supplier-commissioned test forwarded to a customer.[1,2]
§3Apparatus and reagents
§3.1Apparatus
- Not applicable — a procedural protocol
§3.2Reagents and reference materials
- Not applicable
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.
- 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
- 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.