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The USFDA announced next phase of the Quality Management Maturity (QMM) Program for drug manufacturers. FDA is seeking the participation of nine firms in the QMM program.

FDA has developed a protocol with a series of questions in five practice areas – leadership, business continuity, technical excellence, advanced pharmaceutical quality system, and employee empowerment and engagement to evaluate an establishment’s level of QMM. The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.

Request to participate in the voluntary QMM protocol assessment programme shall be accepted through March 25,2004. The objective of the assessment is for FDA to gain experience with the protocol and to evaluate whether use of the protocol will enable a meaningful assessment of the establishment’s quality management practices. Manufacturers of Drug products and APIs, who has undergone at least one human drug surveillance inspection in last 5 years are eligible to participate in the QMM program.

The selected participants will be assessed by a team of 3 trained assessors composed of FDA CDER staff and contractors who will engage directly with establishments, either onsite or in a hybrid (both virtual and onsite) environment. The assessment could take upto five business days, but are distinct from FDAs regulatory inspections. cGMP compliance is evaluated through regulatory inspections. QMM assessments are not used to evaluate compliance with cGMP and are not part of FDA’s inspection authority. QMM assessments focus on evaluating the behaviours, practices, and quality culture within an establishment; Participation in QMM is voluntary.

FDA had conducted two pilot programs to assess the quality management maturity (QMM) of drug manufacturing establishments between October 2020 and March 2022. These provided FDA with insights into how to design and implement a future QMM assessment protocol. For participating establishments, the QMM pilot assessments helped to identify their strengths, weaknesses, and new areas for improvement. For FDA, the goals of the QMM programme include fostering a stronger Quality culture mindset in manufacturers, recognise and acknowledge establishments that have advanced Quality Management Practices, minimise drug shortage risks.

Links and References:

  1. FDA Notice on voluntary QMM programme (25 Jan 24)
  2. CDER Quality Management Maturity
  3. Lessons from CDER’s Quality Management Maturity Pilot Programs
  4. CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development

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