Are you looking for an analytical laboratory to carry out analytical development according to ICH Q14?
What is ICH Q14?
ICH Q14 is an international guideline that proposes a scientific and risk-based approach to the development (risk assessment) and maintenance of analytical methods in the pharmaceutical industry.
It aims to master from the outset:
- API and product knowledge,
- anticipate problems
- and optimize studies to justify development decisions.
The approach relies on tools such as experimental design, risk analysis, and the definition of critical parameters to ensure the reliability and robustness of methods.
Integrated into the Quality by Design (QbD) philosophy, ICH Q14 makes information usable throughout the drug lifecycle, thereby improving the efficiency and quality of development.
Why perform an analysis according to ICH Q14?
Performing an analysis according to ICH Q14 reduces the costs and time associated with unnecessary testing, while capitalizing on acquired data and knowledge from the development stage.
Unlike traditional validation methods, which focus on a final report after testing, ICH Q14 integrates method reliability and robustness from the development stage, thereby enabling decisions to be justified, resources to be optimized, and the drug's lifecycle to be better managed.
FILAB supports you in analytical development according to ICH Q14
FILAB supports pharmaceutical companies in analytical development according to ICH Q14, providing scientific and methodological expertise to:
- Optimize analytical studies and reduce costs and lead times
- Capitalize data from the development stage, facilitating decision-making and ensuring robust methods
- Implement tools based on risk analysis and experimental designs to ensure reliable results
- Provide support throughout the product lifecycle, making information usable and ensuring drug quality
An analytical park dedicated to method development (ICH Q14)
