Quality management systems (QMS) aren't a plug-and-play proposition. Ensuring your QMS investment contributes to the ultimate goal of meeting patient needs—while meeting regulatory compliance expectations along the way—your QMS infrastructure needs to be set up, integrated, and engaged strategically and consistently.
The FDA has earmarked QMM (quality management maturity) as a central component to improving on the pharmaceutical and biopharmaceutical supply chain instability we’ve seen in the wake of the pandemic. That puts a new level of pressure on industry to demonstrate its commitment to quality.
In this short Bioprocess Online e-book, we’ve gathered wisdom and foundational advice on QMS execution from contributing Expert Network team members Tobias Kuners of Koenders (Tob Management) and Grant Mordue (Pro-Active GMP Consulting Ltd.), in addition to insight from contributor James Rolston (KPMG). I’m hopeful you’ll find their insight valuable.