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Quality control of high active substances

High active substances gain ever greater importance in the pharmaceutical and pharmacochemical industry because they can be used in very low concentrations. As the result, the market for traditional pharmaceutical products "only" grows by 7 % p.a., while the share of HPAPI increases by 12 % over the same period of time. In the scientific literature, these substances are known as high-potency active pharmaceutical ingredients (HPAPI).

The handling of HPAPI is regulated by law in Switzerland. Workplaces where these substances are handled need to be risk-assessed and appropriate protective measures defined. These protective measures are divided into technical, organisational and personal protective measures.

Human, product and environmental safety requirements are not limited to the production process, but also have to be complied with in quality control. Analysis service providers such as UFAG LABORATORIEN AG are well position to comply with the new requirements for the handling of high active substances and have put into place an infrastructure that ensures the safe handling of these substances for the purpose of analysis.

In his article on the “Quality control of highly active substances”, published in Chemie Plus 06/2012 [in German], Rainer Walz outlines the definitions of HPAPI, the legal requirements for such substances as well as their handling during quality control analyses.

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