Active Pharmaceutical Ingredients

Guidance Docs
This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, (originally entitled Bulk Pharmaceutical Chemicals). The ISPE API Baseline Guide also incorporates and builds on new regulations and guidance
Training
Get current information on the manufacture of active pharmaceutical ingredients, components, and excipients, while gaining an understanding of unit, labeling and packaging operations. Review critical process equipment...
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...