- What is MIATA?
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is a set of regulations, codes, and guidelines for the manufacture of drugs, medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). Adherence to GMP ensures the manufacture of safe clinical products.
is the practice of applying the principles established under GLP to analyze samples obtained from clinical trials and generate data to be used in regulatory submissions. Adherence to GCP principles ensures the reliability and integrity of data generated by analytical laboratories.
is a laboratory management concept intended to promote the quality and validity of test data. GLP covers the organizational infrastructure and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported.
Studies conducted using methodologies and/or assays which have not been subjected to a qualification and or validation process, and for which performance parameters have not been established
Analytical Methods: A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods. Steven Walfish, December 2006
These definitions and references were provided under the appreciated leadership and input of the following members of the MIATA community:
Michael Kalos, University of Pennsylvania – Marcella Sarzotti Kelsoe, Duke University – John Hural, HVTN, Fred Hutchinson Cancer Research Center – Steffen Walter, Immatics