Adequately establishing contamination risk in drug products

RSSL's Alan Cross explains recent changes within the US Pharmacopoeia (USP) and European Pharmacopoeia (EP).


In the June 2018 issue of Cleanroom Technology, Alan Cross RSSL Technical Specialist, Metals Laboratory, explains how recent changes within the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) put emphasis on risk assessment for the likelihood of contamination as opposed to enforcing mandatory testing in drug products.

Testing for elemental impurities is a vital step in drug product manufacturing to ensure that the quality, purity and consistency of the pharmaceutical yield is maintained. Until recently, manufacturers were required to carry out a wet chemistry heavy metals test to meet the industry standards regulated by the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP). Recent updates of these legal frameworks have removed the test to be replaced by specific elemental testing against validated methods using expensive analytical equipment.

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