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A 503B facility must meet all of the above, plus significantly more intensive CGMP-driven requirements: viable and nonviable particle monitoring in ISO 5 areas every production shift, weekly monitoring in ISO 7 and 8 areas, full process and equipment validation through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, and comprehensive batch records for every lot produced

Xu Z, Chen D, Hu Y, Jiang K, Huang H, Du Y, et al

& Kullak-Ublick, G

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& Zou, D

[A] Jens Juul Holst: What happened after the LEADER trial was that everybody scratched their head and asked: how is this possible