• NMR Spectroscopy – 300 mHz​
  • A new tripartite high level technical guidance harmonising the scientific and technical principles relevant to design, development and manufacture of drug substances as part of a total control strategy designed to ensure product quality and consistency.
  • Harmonisation
  • Facilitate innovative development over the product lifecycle in order to improve product and process understandin.
  • no new regulatory requirements.
  • Utility for regulators & industry.
  • ICH Q7: Good Manufacturing Guides for Active Pharmaceutical Ingredients
  • ICH Q11: Development and Manufacturer of Drug Subtances
  • Gap Analysis
  • Advise and guidance on bridging the gap
  • Documentation
  • Supervising the compliance
  • ICH Q7: Good Manufacturing Guides for Active Pharmaceutical Ingredients
  • ICH Q11: Development and Manufacturer of Drug Substances
  • Gap Analysis
  • Advise and guidance on bridging the gap
  • Documentation
  • Supervising the compliance