as of 2018 - 12 - 03

14.F Stability testing

14.F Stability testing
Here you will find answers to the following questions:

What is the purpose of stability testing?

On what products is stability testing carried out?

What guidelines apply to stability testing?

What are the different types of stability testing?

What needs to be observed during storage?

What are the technical requirements for carrying out stability testing (climatic test cabinets/rooms)?

What has to be observed when carrying out tests for stability studies?

How are storage and transport conditions determined?

How are retest periods (for active ingredients) and shelf lives (for medicinal products) determined?

How can bracketing and matrixing be used to reduce costs?

How should the data be statistically evaluated (extrapolation)?

What requirements should the documentation meet?

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