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	<title>nitrosamine risk assessment &#8211; Risk Publishing</title>
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		<title>Nitrosamine Impurity Risk Assessment: The 2026 Guide for Pharma Compliance Teams</title>
		<link>https://riskpublishing.com/nitrosamine-risk-assessment-checklist/</link>
		
		<dc:creator><![CDATA[Chris Ekai]]></dc:creator>
		<pubDate>Wed, 02 Aug 2023 13:33:44 +0000</pubDate>
				<category><![CDATA[Risk Assessment]]></category>
		<category><![CDATA[A practical nitrosamine impurity risk assessment guide: FDA CPCA acceptable-intake limits]]></category>
		<category><![CDATA[and the August 2025 deadline.]]></category>
		<category><![CDATA[nitrosamine risk assessment]]></category>
		<category><![CDATA[root causes]]></category>
		<category><![CDATA[the three-step process]]></category>
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					<description><![CDATA[On July 13, 2018, the FDA recalled valsartan after the probable carcinogen NDMA was found in active ingredient from China&#8217;s Zhejiang Huahai Pharmaceutical. That contamination turned nitrosamine impurity risk assessment into a global regulatory mandate. By February 2023, more than 18 million bottles of blood-pressure drugs had been pulled from US shelves. That single contamination ... <a title="Nitrosamine Impurity Risk Assessment: The 2026 Guide for Pharma Compliance Teams" class="read-more" href="https://riskpublishing.com/nitrosamine-risk-assessment-checklist/" aria-label="Read more about Nitrosamine Impurity Risk Assessment: The 2026 Guide for Pharma Compliance Teams">Read more</a>]]></description>
		
		
		
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