ICH Q7

Training
This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7 Guideline. This online course covers the...
Training
This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common....
Guidance Docs
This GMP Regulation Handbook represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing...