QMM Assessment Tool Prototype Launched by FDA

The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol.

CDER is implementing the voluntary program which would encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (cGMP) requirements. The outcomes of the prototype evaluation will help inform the development of the QMM assessment tool, the agency says.

Drugmakers eligible to participate in the program are those who manufacture, prepare, propagate, compound, or process drugs or APIs currently in commercial distribution in the U.S. and have had at least one human drug surveillance inspection in the prior five years with an outcome of no action or voluntary action indicated. The agency is accepting requests to participate through March 25.

Read more about the QMM prototype evaluation program, including how to participate, here.

To read the whole story, click here to subscribe.

Related Topics