High Potency Compounds Manufacturing GMP and Environment Health Safety (EHS) Aspects Dr. Jürgen Fleckenstein Boehringer Ingelheim GmbH Correspondence: Dr. Jürgen Fleckenstein, Boehringer Ingelheim GmbH, CDept Environment Protection & Safety, 55215 Ingelheim a. Rhein (Germany), e-mail: juergen.fleckenstein@ing.boehringer-ingelheim.com The manufacture of highly potent compounds has become an emerging issue in the pharmaceutical industry in the recent years, since more and more drugs have been developed acting already in very low doses and often showing low solubility.
This applies to almost every therapeutic field, e.g. oncology products, cardiovascular products or medication to treat pulmonary diseases.
Derived from that, also the requirements on operators protection and cleaning validation have increased a lot.
A holistic view on the matter is necessary to finally decide on concepts and technology if it comes to investments for facilities foreseen to manufacture highly potent drugs.
Decisions should be based on risk rather than following a compound classes approach, since many APIs have overlapping physiological properties.
The partially unclear regulatory environment makes these decisions even more difficult, forcing the pharmaceutical companies to develop and follow their own philosophies.
This article highlights GMP and industrial hygiene aspects as well as regulatory requirements. Examples for contained and dedicated equipment from API and drug products manufacturing at different stages are shown. Key words Cleaning validation • Containment • Exposure control • Industrial hygiene • Potent compounds • RiskMaPP | 
