Stability testing according to Q1A (R2):

Basics and technical solutions

Stability testing according to the ICH Q1A (R2) guideline is an important and indispensable step in the drug approval process. Extensive long-term and accelerated stability testing must be carried out to determine the shelf life of the active pharmaceutical ingredient (API) and the finished pharmaceutical product (FPP). The storage conditions, temperature and relative humidity specified in the ICH guidelines must be strictly observed in the process.

Constant climate chambers used for stability testing have to be absolutely precise and reliable in order to meet the strict requirements for ICH guidelines.

In this whitepaper, you can read which technical solutions are available to ensure smooth continuous operation and which factors should be taken into account when choosing a constant climate chamber.

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You will find these topics in our whitepaper:

  • Stability testing according to ICH Q1A (R2)
  • Photostability tests according to ICH Q1B
  • Technical solutions: Constant climate chambers
  • Heating and cooling technology
  • Air ducting
  • Water management
  • Light
  • Continuous operation
  • Programming and documentation
  • Qualification

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