On 19 April 2018, the European Medicines Agency (EMA) issued a revised copy of their "Questions and answers on implementation of risk-based prevention of cross-contamination in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)" hereafter, known as "the guidance." Of particular interest in the guidance is Q4.
Q4 of the guidance indicates the following:
Q4. What competencies are required for the person developing the health-based exposure limits (HBEL)?
A: Health-based exposure limits should be determined by a person who has adequate expertise and experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in the determination of health-based exposure limits such as occupational exposure limits (OEL) or permitted daily exposure (PDE).
Where experts are contracted to provide the HBEL, contractual agreements in compliance with Chapter 7 requirements should be in place prior to work being conducted. It is not considered acceptable for manufacturers to “purchase” HBEL assessments without recording and assessment of the suitability of the provider (including the specific technical expert) as a qualified contractor.
In response to this section of the guidance, Affygility Solutions provides the following: While this statement, appears to be targeting "technical experts" that are contractors, unfortunately, there is a lot of context surrounding this statement that is missing from the EMA Q&A document. This includes that there must be appropriate documentation to support the qualifications of the person performing the HBEL assessment, no matter if they are internal to the pharmaceutical company or an external contractor.
Expert toxicologists are also required when creating occupational exposure limits (OEL) monographs. An expert toxicologist has an advanced degree (M.Sc. or Ph.D.) in a toxicology related field, approximately 5+ years of professional toxicology experience with being mentored by a certified toxicologist and has published peer-reviewed journal articles in toxicology-related publications.
OEL Fastrac is the award-winning digital platform for providing OEL, ADE (PDE) monographs to the pharmaceutical industry. Affygility’s OEL/ADE monographs have been widely accepted by EMA, PIC/S, and ANVISA authorities that have performed inspections on pharmaceutical companies. Certified toxicologists and industrial hygienists with decades of industry experience
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