Skip to main content
Connecting Pharmaceutical Knowledge
Conferences & Training
Exhibit & Sponsorships
Membership & Communities
Communities of Practice
Affiliates and Chapters
Women in Pharma
Career Opportunities in Pharma
Publications & News
Guidance Document Portal
Pharmaceutical Engineering Magazine
Concept & Discussion Papers
Initiatives & Programs
Facility of the Year Awards
Regulatory & Initiatives
Enter your ISPE | International Society for Pharmaceutical Engineering username.
Enter the password that accompanies your username.
Forgot My Username
Forgot My Password
Create A New Account
You are here
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...
ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course
This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common....
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...