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 quality as developed by ICH.  It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.

The ICH Q7 regulation handbook is used in association with several ISPE training courses:

• Applying the GMPs (G03)
• Pharma Facilities Project Management Training Course (T26)
• ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
• Biotechnology Manufacturing Facility Design Training Course (T31)
• Process Validation Training Course (T46)

Attendees of the training course receive a complimentary copy of this publication.