Stability Studies & Storage
The main objective of stability studies is to guarantee the integrity of the product over time, ensuring its efficacy, quality and patient safety
Today, the authorities are increasingly vigilant. For example, between 2018 and 2023, the FDA issued more than 260 warning letters and recalled more than 700 products between 2012 and 2021.
For manufacturers, it is crucial to prevent any delay in marketing and any product recall, in order to preserve their brand image, maintain their competitiveness and ensure continuity of production.
It is therefore essential to put in place an optimal stability program, both for patient safety and for the interests of the manufacturer.
To ensure a rigorous assessment, Eurofins BioPharma Product Testing’s (BPT) network of laboratories offers manufacturers five major advantages:
- An unequalled storage capacity
- In-depth knowledge of regulatory requirements
- Extensive experience in designing stability studies
- State-of-the-art equipment in our analytical laboratories
- Proven expertise in interpreting trends
Discover our GMP stability services
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