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Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).
For example, the OCABR [22] procedure guarantees that for the vast majority of the vaccines used in the EU, no batch of vaccine is released to the market in member states without first undergoing an independent quality control by a laboratory of the OMCL Network [9] in addition to the release test conducted by the manufacturer.
WHO guidelines for biological [nb 1] reference materials [9] provide the terms: [nb 2] Reference standards: materials that are used as calibrators in assays International biological measurement standard: a biological substance provided to enable the results of biological assay or immunological assay procedures to be expressed in the same way ...
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India.NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC ...
The formal definition of calibration by the International Bureau of Weights and Measures (BIPM) is the following: "Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties (of the calibrated instrument or ...