Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program

Streszczenie

The Food and Drug Administration (FDA) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the third year of the voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with the assessment tool and process. The continuation of this voluntary program is needed to assure that these assessments enable consistent and meaningful evaluations of establishments' quality management practices and provide useful feedback for the establishments. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.