Analytical validation: what if it lasts for a long time?

The role of the ICH in harmonizing quality standards

Since its inception in 1990, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) mission has been to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner while meeting high standards. Quality must be ensured throughout the lifecycle of a medicine (from raw material to finished product). Ensuring the quality of medicine through quality control involves implementing various practices and procedures to ensure that the pharmaceutical product complies with defined standards. One of the fundamental practices is the use of analytical methods.

The requirement to validate analytical methods

All analytical methods used to control the quality must be adequately validated based on the purpose of the analysis. Validation is a regulatory requirement, and it is defined as “the documented evidence establishing a high degree of assurance that the analytical procedure employed will consistently produce reliable analytical data.”

The validation of analytical methods must be continuously monitored to ensure that the results generated are always valid. Indeed, changes in the ICH’s recommendations or regulations specific to certain markets, or even the evolution of internal specifications, constitute reasons that require the revalidation of specific method parameters to meet the requirements. The impact of these changes must be systematically controlled to ensure the validated status of analytical methods, achieved through periodic review of analytical methods.

The benefits of consistent analytical validation

Analytical method validation provides evidence of method suitability, and this evidence is crucial for internal quality control, external audits, and regulatory inspections (ANSM, EMA, FDA, and many others). By validating analytical methods, pharmaceutical industries can have confidence in the data generated, enhance regulatory compliance, and ensure the safety and efficacy of pharmaceutical products.

How ProductLife Group can support your analytical validation

Thanks to its experience, ProductLife Group offers support in maintaining the validation of analytical methods through the conduct of an “Analytical Method Review” based on current regulations (ICHQ2(R1) and internal specifications. Our teams are at your disposal to answer your questions and assist you in meeting your needs. Contact us here.

Bibliography

1. VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1); ICH.
2. GUIDE DES BONNES PRATIQUES DE FABRICATION; ANSM.