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ICH Q7
ICH Q7
Training
ICH Q7: Introduction and Quality Management
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
ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course
This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common....
Guidance Docs
GMP Regulation Handbook: Active Pharmaceutical Ingredients, ICH Q7
1 September 2016
This GMP Regulation Handbook represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing...
