🏭FDA Announces QMM Assessment Protocol Evaluation Program for Drug Manufacturers
Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The content outlines a voluntary FDA program aimed at improving quality management practices in drug manufacturing. Participation could enhance compliance and operational efficiency, potentially leading to reduced regulatory headaches and improved market competitiveness for drug manufacturers.