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ICH-Q1 Drug Stability is a Course

ICH-Q1 Drug Stability

Time limit: 180 days

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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.