ICH-Q1 Stability Training

ICH-Q1 Stability Training

Issued by Northeastern University

Participants in the ICH Q1 training explain the quality guidelines on Stability, including Stability Testing of New Drug Substances and Products (Q1A, R2); Photostability Testing of New Drug Substances and Products (Q1B); Stability Testing for New Dosage Forms (Q1C); Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Q1D); Evaluation of Stability Data (Q1E); and Stability Data Package for Registration Applications in Climatic Zones III and IV (Q1F).

Skills

Earning Criteria

  • Understood the expectations on stability studies and appreciated use of risk management
  • Described the WHO guidelines on stability testing of active pharmaceuticals in climatic zones III and IV, which replaced ICH-Q1F.
  • Understood and explained the evaluation used for stability testing as explained in ICH-Q1E
  • Described the stability testing of drug substances and products as outlined in the ICH-Q1A(R2) and ICH Q5C guidelines.
  • Defined stability testing for new dosage forms as outlined in ICH-Q1C.
  • Explained the importance of photostability testing of new drug substances and products in ICH-Q1B.
  • Demonstrated the bracketing and matrixing ICH-Q1D