e-Learning: Stability Testing in the ICH Region

Program

Modul 1 Regulatory requirements

• ICH guidelines
• WHO guidelines
• Additional stability guidance documents

After having passed this module you know the regulatory requirements on stability testing by ICH, WHO and other specific guidelines.

Modul 2 Factors that influence stability testing

• Climatic zones
• 'Quality by Design' - Influencing factors
• Stability studies - Possible changes
• Container closure - Impermeable vs semipermeable
• Transport
• End user

After having passed this module you have a deep understanding of how climatic conditions, product parameters, changes, container closure systems and the end user can influence the stability testing.

Modul 3 Stability test requirements

• Long-term, accelerated, stress testing
• Photostability
• In-use stability
• Stability throughout life cycle

After having passed this module you know which tests and test-paramenters are required and you have received tips from practice.

Modul 4 Bracketing and matrixing

• Designs
• Bracketing
• Matrixing

After having passed this module you can define bracketing and matrixing and have received examples to the designs.

Modul 5 Shelf-life and extrapolation - challenges

• Definition of the shelf life
• Data required
• Extrapolation
• Text conditions
• Post approval

After having passed this module you can define shelf-life and have an understanding of the necessary data and the extrapolation-requirements.

Modul 6 Impact of changes on the stability

• Relevant guidelines
• Kinds of changes
• Stability-indicating parameters
• Examples

After having passed this module you are familiar with the regulatory background and have deepened your understanding of different kinds of changes and their influence on the stability.

Modul 7 Challenges for biotechnological products

• Relevant guidelines
• Challenges
• Batch selection
• Forced degradation studies
• Extrapolation
• Additional challenges

After having passed this module you know the specific regulatory stability-requirements of biotechnological products in contrast to chemicals.

Program

Modul 1 Regulatory requirements

• ICH guidelines
• WHO guidelines
• Additional stability guidance documents

After having passed this module you know the regulatory requirements on stability testing by ICH, WHO and other specific guidelines.

Modul 2 Factors that influence stability testing

• Climatic zones
• 'Quality by Design' - Influencing factors
• Stability studies - Possible changes
• Container closure - Impermeable vs semipermeable
• Transport
• End user

After having passed this module you have a deep understanding of how climatic conditions, product parameters, changes, container closure systems and the end user can influence the stability testing.

Modul 3 Stability test requirements

• Long-term, accelerated, stress testing
• Photostability
• In-use stability
• Stability throughout life cycle

After having passed this module you know which tests and test-paramenters are required and you have received tips from practice.

Modul 4 Bracketing and matrixing

• Designs
• Bracketing
• Matrixing

After having passed this module you can define bracketing and matrixing and have received examples to the designs.

Modul 5 Shelf-life and extrapolation - challenges

• Definition of the shelf life
• Data required
• Extrapolation
• Text conditions
• Post approval

After having passed this module you can define shelf-life and have an understanding of the necessary data and the extrapolation-requirements.

Modul 6 Impact of changes on the stability

• Relevant guidelines
• Kinds of changes
• Stability-indicating parameters
• Examples

After having passed this module you are familiar with the regulatory background and have deepened your understanding of different kinds of changes and their influence on the stability.

Modul 7 Challenges for biotechnological products

• Relevant guidelines
• Challenges
• Batch selection
• Forced degradation studies
• Extrapolation
• Additional challenges

After having passed this module you know the specific regulatory stability-requirements of biotechnological products in contrast to chemicals.

Program

Program

Modul 1 Regulatory requirements

• ICH guidelines
• WHO guidelines
• Additional stability guidance documents

After having passed this module you know the regulatory requirements on stability testing by ICH, WHO and other specific guidelines.

Modul 2 Factors that influence stability testing

• Climatic zones
• 'Quality by Design' - Influencing factors
• Stability studies - Possible changes
ystems...