Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for a limited number of establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a prototype assessment protocol to evaluate quality management maturity (QMM). The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain experience with the prototype assessment protocol and to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment's quality management practices while providing useful feedback for the establishment. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.
Abstract as published in the Federal Register.
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