You need analytical validation according to ICH Q14
What is ICH Q14?
Firstly, the acronym ICH Q14 refers to a guideline that describes risk-based scientific approaches for the development and maintenance of analytical procedures suitable for assessing the quality of pharmaceutical substances and products. It aims to harmonise standards in the pharmaceutical industry on an international scale.
What is the scope of ICH Q14?
It applies to new or revised analytical procedures used for release and stability testing of commercial pharmaceutical substances and products (chemical and biological/biotechnological). The guidance may also be applied to other analytical procedures used as part of the control strategy following a risk-based approach.
Analytical development according to ICH Q14 therefore requires, among other things, skills in assessing the stability of a formulation over time and in chemical composition analysis.
Consequently, only a laboratory with state-of-the-art analytical equipment capable of performing analyses on pharmaceutical products is in a position to carry out analytical development in accordance with ICH Q14.
Why carry out an ICH Q14 analysis?
The aim of this standard is to rationalise and improve analytical development approaches. Its main objective is to ensure the quality, safety and efficacy of pharmaceutical products.
FILAB meets your analytical validation needs according to ICH Q14
In order to support manufacturers in the development and quality control of their products, by following the regulatory evolutions, the FILAB laboratory provides a state-of-the-art analytical park of 5200m² allowing the implementation of the analytical validation according to ICH Q14
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Analysis by amalgamator
ICP-AES analysis
