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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.
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
Automatic test equipment diagnostics is the part of an ATE test that determines the faulty components. ATE tests perform two basic functions. The first is to test whether or not the Device Under Test is working correctly. The second is when the DUT is not working correctly, to diagnose the reason.
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.