Due to the complexity involved in handling cytotoxic and cytostatic substances, manufacturers of high potency active pharmaceutical ingredients (HAPIs) and the resultant drug products are faced with more onerous manufacturing challenges than the regulatory Good Manufacturing Practice (GMP) rules and guidelines applicable to sterile drug manufacture.
High potency compounds are classified according to their potential to cause harm at low doses, at or near the therapeutic dose or lower. A traditional limit of 1/1000th of the low clinical dose has been in use, but note – this is not a health-based measure. This limit may be insufficient or indeed be excessive in setting protection limits.
The European Medicines Agency (EMA) has released a new draft guideline on setting health-based exposure limits. One definition for a high potency molecule is based on health effects: an occupational exposure limit (OEL) set at or below 10 micrograms per cubic metre of air (10µg/m3) as an eight-hour time weighted average (8hr TWA).
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