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IPQ Inside the global regulatory dialogue

Look Forward, Not Backward, in API Process for Impurity Risks, Industry Experts Urge EU Regulators

Mar 20th, 2012

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API industry experts are urging European regulators to focus on the risks from impurities that enter at the end of the API synthesis process rather than on earlier pre-intermediate stages where the risks may be considerably less and fully mitigated by later processing.

In the wake of current regulatory efforts in Europe to require more information on impurities further back in the synthesis of starting materials (IPQ “The News in Depth” March 21, 2011), industry representatives are cautioning that impurities potentially entering the process in the final steps are more likely to end up in the API.

The case for this focus was made by DSM Anti-Infectives External Regulatory Affairs Manager Chris Oldenhof, a veteran industry API expert, at the APIC annual meeting in Munich, Germany in November.

To illustrate the potential impurity risks later in the API process that support his position, Oldenhof discussed: ● relevant guidance in ICH Q11 ● sources of impurities in the manufacturing process ● the total inflow of impurities into the final manufacturing step ● the “tough questions” that need to be considered on where the risks lie, and ● the conclusions that the evidence points to.

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