ICH Q7

Training
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
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....
Active Pharmaceutical Ingredients, ICH Q7
Guidance Docs

GMP Regulation Handbook: Active Pharmaceutical Ingredients, ICH Q7

This GMP Regulation Handbook represents the FDA's current thinking regarding GMPs for manufacturing APIs under an appropriate system for managing...