What’s new with the ICH Q14 for Analytical development?
To regulate drug production, there are a multitude of documents that pharmaceutical companies can refer to for managing a quality system: the European Pharmacopoeia, the USP (United States Pharmacopeia), the Annex regulations, the ICH (International Conference on Harmonisation), the EMA Q&As, and last but not least, the famous GMP (Good Manufacturing Practice).
How do you navigate through the multitude of regulations?
The ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) can provide valuable support as it is a project that brings together drug regulatory authorities from Europe, Japan, and the USA, and pharmaceutical industry experts to discuss the technical and scientific aspects of pharmaceutical product registration.
In particular, ICH Q14 aims to establish new standards in the development of analytical procedures and methods. Let’s take a closer look at what ICH Q14 is about.
Harmonizing Reference Agencies for Analytical Regulation: A Way to Verify the Quality of Pharmaceutical Products
ICH Q14 promotes an approach based on science and risk together with knowledge. Preliminary knowledge of a product plays an important role in identifying the appropriate analytical techniques. ICH Q14 encourages using innovative technologies to improve the quality and safety of pharmaceutical products. This guideline offers companies the opportunity to optimize their processes and reduce time to market while presenting the challenge of adapting to more advanced analytical practices. This aspect is always a bit daunting because change and technological advancement require a great effort.
Furthermore, its implementation requires close and continuous collaboration between pharmaceutical companies, regulatory authorities, and the academic world.
The Advantages of ICH Q14
The great advantage, however, is that Q14 aims to:
- harmonize regulatory standards globally,
- thereby facilitating international trade and
- ensuring consistent pharmaceutical quality.
In conclusion, ICH Q14 not only raises the standards for the development of analytical methods and procedures but also points the way to a more innovative and safe pharmaceutical industry, ensuring access to high-quality products for patients globally.
