Guidelines for Stability Studies and Storage
In accordance with the guidelines established by the International Committees on Harmonisation of Technical Requirements for Registration of Medicinal Products for Human (ICH)(1) and Veterinary (VICH)(2) Use, these studies aim to ensure that medicinal products and active ingredients retain their quality, safety and efficacy throughout their life cycle. They are essential for the regulatory approval/certification and marketing of products, ensuring that patients and animals receive safe and effective treatments.
(1) ICHQ1(A): Stability testing: stability testing of new drug substances and products (R2)
(2) VICH GL3: Stability testing of new veterinary drug substances and medicinal products
Why choose Eurofins BioPharma Product Testing?
Eurofins BPT conducts stability studies on all types of medicinal products, including biologicals, bulk material, drug substances, intermediates and final packaged products. In accordance with ICHQ5C(3) guidelines, all tests for identity, purity, molecular characterisation and potency are rigorously performed.
(3) ICH Q5C Quality of biotechnological products: stability testing of biotechnological/ biological products
Medical devices
If the device's design and manufacturing processes are well controlled, it is highly likely that it will function as intended. However, many factors can influence how long the device will retain its full functionality. This is why stability studies are necessary.
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