FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. The FDA published a White Paper that discusses the assessment approach planned to be used at establishments participating in the QMM program and describes the five practice areas covered by the prototype assessment protocol.
Read the full White Paper here.