An Overview Of The Role Of Occupational Toxicology In The Pharmaceutical Industry
Since the late 1980’s, the biotechnology, pharmaceutical, and medical device industry has hired numerous professionals to manage occupational toxicology programs. Occupational toxicology programs involve:
1) Researching and reviewing research, pre-clinical, and clinical data for active pharmaceutical ingredients (API)s and isolated intermediates for hazard information. These reviews are conducted to determine potential occupational hazards and assess exposure risks during the processing of these compounds. For early stage compounds, the outcome of these reviews is the assignment of the compound to a specific occupational exposure control band. For later stage compounds, the occupational toxicologist may develop a numerical occupational exposure limit (OEL).
2) Authoring material safety data sheets (MSDS): The occupational toxicology department may be responsible for authoring MSDSs for the APIs and other materials. With the advancement of the Globalization and Harmonization of the Classification and Labeling System, over the next several years there will be a significant amount of work in this area. Companies will need to reevaluate their occupational toxicology programs to ensure an adequate knowledge base.
3) Investigating allegations of adverse exposures. The occupational toxicologist also may work with industrial hygiene and safety personnel to investigate allegations of adverse exposures to APIs in the occupational environment. The investigation process may involve interviewing employees to determine symptoms of exposures, researching both primary and secondary literature sources to determine potential hazards, and working with occupational medical personnel in evaluating the results of medical tests.
4) Performing reproductive hazard evaluations. The occupational toxicologist may also be requested to perform evaluations of the work environment to determine the potential risks to workers that may be in the early stages of the family planning process. Again, this may involve reviewing chemical inventories, research literature sources, and determining potential exposure risks. The process for performing these evaluations should be defined in the company’s occupational toxicology program.
5) Performing ecological impact assessments. In the later stages of the drug development process, the occupational toxicologist may be asked to perform ecological impact assessments to ensure the safe disposal of waste pharmaceutical product or wastewater that is generated during the cleaning of pharmaceutical manufacturing process equipment. This is typically a slight departure from their normal occupational toxicology responsibilities, in that they will be examining the impact on non-human species rather than humans.
6) Developing and maintaining potent compound safety programs. In most cases the occupational toxicologist will work with other departments (industrial hygiene, safety, etc.) to develop and implement a potent compound safety program. These programs are designed to ensure that occupational exposure to APIs in minimized. The occupational toxicology department plays a key role in these programs.
Professionals that manage occupational toxicology programs typically have advanced degrees in a related scientific discipline. The Society of Toxicology (http://www.sot.org) provides a listing of academic programs that offer degrees related to the field of occupational toxicology.
Dean M. Calhoun, CIH is the President and CEO of Affygility Solutions. Affygility Solutions provides a wide variety of EH&S services to the life science industry. These services include: occupational toxicology, industrial hygiene, occupational safety, OSHA compliance, environmental compliance, ,potent compound safety and more.
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