ICH Stability

Ich Stability

PharmSky can perform stability studies according to ICH guidelines to monitor the physical, chemical, biological, and microbiological attributes of products stored under accelerated and real time conditions over a defined period. This data is used to make decisions on material storage conditions, shelf life and labelling requirements and forms a critical component of regulatory submission documentation both before and after registration.

Stability studies are required at various stages throughout a products life cycle, including:

PharmSky can support and manage the GMP stability testing of your product. We offer a wide range of TGA certified and ICH compliant stability storage and testing services, including:

Our storage chambers have been qualified in alignment with regulatory requirements and are continuously monitored to ensure they stay within required limits. Stability programs can be undertaken under the following storage conditions.

Following the conclusion of a trial, storage of samples can continue for as long as required.

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