The aim of the training is to familiarise participants with guidelines concerning medicinal product stability tests and statistical data analysis methods which allow us to evaluate results obtained during such tests and present trends, to identify outliers and to predict the shelf life of a medicinal product.
Training description: Medicinal product stability testing aims to evaluate the impact of different environmental factors such as temperature, humidity, light, to evaluate how product quality changes over time and to determine the shelf life, recommended storage and transport conditions for a medicinal product. Statistical data analysis methods allow us to evaluate results obtained from stability testing, trends present in stability tests, to identify outliers and to predict the shelf life of a medicinal product. The aim of the training is to familiarise participants with guidelines regarding stability tests, in particular, the use of statistical data analysis methods. The course combines practical knowledge of various aspects of the pharmaceutical sector with knowledge of data analysis methods. Individual statistical issues will be discussed from a theoretical perspective and later developed through exercises. After the course, the participants are able to individually suggest the relevant data visualisation and statistical evaluation methods in stability testing.
Requirements: ability to work with a computer in the Windows environment
Training programme:
- Current regulations applicable to stability testing
- Requirements concerning stability testing of finished products
- Requirements concerning stability testing of bulk products and intermediate products
- What factors influence the stability of medicinal products
- What product parameters should be subjected to stability testing
- What are the types of stability tests
- How to use the group / matrix method in stability testing
- How to define transport and storage conditions for medicinal products
- How should data from stability testing be analysed statistically
- What statistical methods should be used to evaluate trends in stability tests
- What statistical methods to use to evaluate outliers
- What are the requirements for stability test records
- What are the technical requirements (stability chambers) for stability testing
- How to class stability chambers
- Example protocol and report on stability test assessment
- Statistical assessment of results obtained from stability testing
- Evaluation of trends in stability tests
- Identification of outliers
- Predicting shelf life
