Navigating the Regulatory Landscape in Cell-Based Operations
In the intricate world of cell-based R&D, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) laboratories, the stakes couldn't be higher—pioneering research and life-saving therapeutics stand as the pillar of achievements. Yet, the stakes are equally high in the realm of regulatory compliance. Stringent standards such as 21 CFR Part 11, Annex 11, ISO 27001, and GAMP 5, 2 ed. are not just demanding; they're the prerequisites for scientific veracity and patient safety.
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