BioPharma EH&S Podcast Episode No. 10 Note: This is the abbreviated script of the podcast, for the more detailed version go to http://potentcompoundsafety.com/?p=642 Cover what we talked about last time in episode number 9 Then I will cover our main topic for today, which is “Industrial hygiene in the pharmaceutical industry.” Discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry. Discussed the topic of “Are you an environmental, health and safety road warrior?”  Get into our main topic for today which is “Industrial hygiene in the pharmaceutical industry.” What I’m going to talk about here is based off of a journal article written by myself, Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, and Angela Coler of Affygility Solutions.  This article is titled “Strategies for preventing occupational exposure to potent compounds” and was published in a 2010 edition of Toxicology Mechanisms and Methods.  In that article, Joe, Angela, and I discuss that since the 1970’s, occupational toxicologists, industrial hygienists and other occupational health professionals in the pharmaceutical industry have recognized that occupational exposure to active pharmaceutical ingredients can cause unintended health effects in workers handling these substances.  In our Advanced Topics in Potent Compound Safety webinar, Dr. Nieusma, always discusses that chemical compounds that are routinely handled in the pharmaceutical industry are unique from other chemicals in that these compounds are designed to have an effect on the human body.  In an occupational setting, if an employee provides a pathway of exposure to a potent compound, there is a high probability that the compound is going to elicit the designed response.  Industrial hygienists and other occupational health professionals in the industry have responded to this hazard recognition by employing strategies for the risk evaluation and control of potent active pharmaceutical ingredients, otherwise known by the term “potent compounds.” The strategies for preventing occupational exposure to potent compounds are very similar to any other industrial hygiene process, and consist of anticipating and evaluating the hazards of potent compounds; determining which of those process activities pose the highest risks; evaluating those risks, and finally, controlling potential exposures primarily through engineering devices.  These strategies should be applied at all stages of pharmaceutical product development including discovery, pre-formulation, initial test batches, pilot plant, scale-up, and production.  These strategies can be applied to initial discovery of a potent compound by an innovator company or to the development of a product coming off patent by a generic pharmaceutical company. Don't go into the definition of a potent compound, refer to article So, let’s now talk about our first strategy component, the first component is Evaluating the Hazards of Existing and New Compounds Prior to the introduction of any new APIs into the workplace, a thorough scientific literature search on the specific or similar compounds should be conducted.  If your company is just getting started in developing a potent compound safety program, a thorough literature search should be performed on pharmaceutical products already in the company’s portfolio – either in development or already on the market.  The industrial hygiene professional needs to gain an understanding of the potential hazards of all of the company’s products. While retrieving literature and understanding the hazards may seem like a fairly simple task, for new compounds early in the development process it is often challenging to find information that is relevant to an occupational exposure sc