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, such as:

ICH Q7
ICH Q9
GAMP 4
21 CFR Part 11
Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (cGMP)
FDA Draft Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

Key features of the Guide include:

Active Pharmaceutical Ingredient characterization
Critical process steps
Potential contamination
Good Engineering Practice
Levels of protection
Critical process parameter
Critical instruments
Critical unit operation (new)
Contamination review (new)
Design qualification (new)
Intended patient use (new)
Direct, indirect, and no impact systems (new)
Critical and non-critical components (new)
Facility designation (new)
Process Analytical Technologies (new)
process review (new)
Risk to patient (new)
Understanding of process (new)

In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the U.S., and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.