Analytical validation according to the European American and Japanese pharmacopoeias

First of all, the pharmacopoeia is a regulatory work for pharmaceutical manufacturers and health professionals. It groups together the regulations relating to raw materials as well as the analytical methods to be used for quality control analysis on pharmaceutical products.

There are different pharmacopoeia references written by the competent authorities:

• International pharmacopoeias such as the European Pharmacopoeia drawn up by the Council of Europe or the International Pharmacopoeia drawn up by the WHO
• National pharmacopoeias such as the French pharmacopoeia drawn up by the ANSM or the American pharmacopoeia drawn up by the FDA.
• The Japanese pharmacopoeia (Japanese Pharmacopoeia -日本薬局方).

In addition, analytical validation consists of guaranteeing the performance of an analytical method by examination and provision of objective evidence, with regard to the expected use of the product. It also makes it possible to estimate its measurement uncertainties.

Pharmacopoeias vary from area to area. Consequently, the European, American and Japanese pharmacopoeias have significant differences that influence the analytical validation methods.

Therefore, the support of a laboratory with expertise in analytical validation and detailed knowledge of the European, American and Japanese pharmacopoeias is indispensable for analytical validation needs according to the European, American and Japanese pharmacopoeias.