7/8 May 2024
The US Food and Drug Administration is launching the next phase of its Quality Manufacturing Maturity (QMM) programme and is seeking companies to voluntarily participate. This will be done through a so-called "QMM Prototype Assessment Protocol Evaluation Programme".
According to the FDA, this includes
This requires a strategic integration of "business decisions and manufacturing operations with quality practices and technological advancements".
The QMM programme is therefore intended to encourage drug manufacturers to implement quality management practices that "go beyond current good manufacturing practice (CGMP) requirements"!
The prototype protocol evaluation mentioned above is designed to determine a facility's level of QMM. To evaluate this, the FDA is looking for nine companies to participate voluntarily. The prototype includes a series of questions in five areas:
The results of this programme will feed into the further development of the assessment process to be used for the subsequent QMM programme.
Further information can be found on the FDA website.