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

Evidence

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