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Navigating the realm of pharmaceutical and biotech sectors, Quality Leaders often face the uphill battle of managing and overseeing CMOs. Often, these Contract Manufacturing Organizations come as mandates from higher management or procurement teams. As the MAH, you're left to ensure their systems resonate with yours, making you primarily accountable for product quality, safety, efficacy, and cGMP compliance. A challenging task when these CMOs scatter globally, each with its time zones, cultural nuances, and language barriers.
Yet, amid the layers of complexities like a lack of familiarity with the CMO, maintaining constant readiness for Health Authority inspections, and managing the vast sea of regulatory nuances, it's easy to feel overwhelmed.
But there's a method to the madness. Let's guide you through it:
Phase 1: The (Pre) Qualification Phase
Phase 2: The Selection Phase
Manufacturing:
QC (Quality Control):
QA (Quality Assurance):
RA (Regulatory Affairs):
Phase 3: The Working Together Phase
At GMP BRIDGE, we view CMO management not just as a process, but as an art - a crucial element in solidifying product excellence. Venture with us to unearth the true depth of CMO governance. Looking for expertise in CMO Management and Quality Oversight? Let's Talk!
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