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Technical Expert Assessment for the Determination of HBEL
On 19th 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:
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.
In order to streamline the process for a pharmaceutical company to “pre-qualify” Affygility Solutions as an expert toxicology contractor, we have prepared a contractor assessment package. To request a copy of this package, please contact us.
In addition, as a reminder, all OEL Fastrac clients receive periodic monograph updates at no additional costs.