Laboratory analysis in line with GMPs

GMP (Good Manufacturing Practices), known in French as BPF (good manufacturing practices), are defined by the WHO (World Health Organization) as “elements of quality assurance that ensure products are consistently produced and controlled according to quality standards appropriate to their intended use and specified in the marketing authorization.”

In the pharmaceutical industry, GMP principles are particularly important given the high level of quality required in the development, manufacture, and control of products.

Indeed, GMP incorporates quality assurance throughout the pharmaceutical product development, manufacturing, and control process, rather than only for the finished product.

GMP principles apply equally to pharmaceutical products for human health and animal health.

For several years now, the competent authorities have sought to harmonize GMP worldwide, notably through the creation of new international guidelines: the ICH guidelines.

The ICH Q7, Q8, Q9, and Q10 guidelines fully incorporate GMP principles at different levels. For example, ICH Q7 defines GMP for active pharmaceutical ingredients (APIs), while ICH Q8, Q9, and Q10 refer to the quality by design approach to GMP.