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ICH-Q1 Drug Stability is a Course

ICH-Q1 Drug Stability

Time limit: 180 days


Full course description

Students will be able to describe the difference between small molecule and protein drug stability testing.  In addition, students will be able to explain the  ICH-Q1 guidelines and how they are applied to drug development and approvals. This course would be most suitable for: drug developers, drug manufacturers, regulatory affairs, regulatory assessors, and site inspectors.

Course Outcomes

  • Understand the expectations of stability studies and appreciate use of risk management
  • Describe the stability testing of new drug substances and products as outlined in the ICH Q1A(R2) and define stability testing for new dosage forms in ICH-Q1C.
  • Describe the WHO guidelines on stability testing of active pharmaceuticals in climatic zones III and IV, which replaced ICH-Q1F.
  • Explain ICH Q5C guideline.
  • Explain the importance of photostability testing of new drug substances and products in ICH-Q1B.
  • Demonstrate the bracketing and matrixing ICH-Q1D
  • Evaluation of stability data as explained in ICH-Q1E.

Successful learners can earn a Level 1 badge than can be showcased on their digital profile or resume.

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