Neil Walsh
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Are we proactively solving the nitrosamine crisis?

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Is a proactive approach the way to mitigate risk?

Recently, the FDA has re-issued the 2018 guidance to industry, “M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk”. Is this going to help? Or should we have a higher focus of qualitative analysis up front?

Companies need to take a look all facets of their supply chain and manufacturing process. They should be able to ensure they can control the active pharmaceutical ingredients (APIs) throughout the process, whether they do it in their own facility or it is outsourced.  

How are they going to do this?

Why you need a control strategy

A control strategy is a planned set of controls derived from current product and process understanding that assures process performance and product quality (ICH Q10, Ref. 8).

A control strategy can include, but is not limited to, the following:

  • Controls on material attributes (including raw materials, starting materials, intermediates, reagents, solvents and primary packaging materials)
  • Facility and equipment operating conditions
  • Controls implicit in the design of the manufacturing process
  • In-process controls (including in-process tests and process parameters)
  • Controls on drug substance and drug product (e.g., release testing)

How to ensuring better data, by seeing it all

Work previously presented by Prof. Sörgel, at the Institute for Biomedical and Pharmaceutical Research, Nuremberg, Germany on the benefits of this workflow is that with SWATH® Acquisition you are creating a digital record of all the analytes in the sample.

This approach shows:

  • That a control strategy supports all workflows to be used in impurity analysis: from impurity profiling to quality control B
  • The approach is also suitable for all Pharma QC requirements: 21 CFR Part 11 compliance, MS/MSALL with SWATH® Acquisition, high-resolution mass accuracy, reproducibility and sensitivity to detect smallest traces of impurities
  • General unknown comparative screening is easy-to-use “gold standard” workflow in pharmaceutical quality control analysis. It shows significant strengths to monitor batch-to-batch production of active medicinal components.
  • Statistical analysis for either in-depth impurity analysis or to obtain information about origin of active medicinal component

Watch out for our next blog where we examine some of the analytical challenges of these molecules.

You can learn more about how LC-MS/MS solutions can identify, quantify and monitor the required levels of nitrosamine impurities by accessing technical notes and a webinar addressing the characterization and quantification of the genotoxic impurities.

Learn More >

This is part two of an ongoing blog series on genotoxic analysis. Read part one: “What have we learned from the nitrosamine crisis?” and part three: “Developing a method for nitrosamine analysis in pharmaceutical products“.

Neil Walsh
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Neil Walsh
Neil Walsh is the Senior Manager for Pharma global strategic marketing at SCIEX. In this role, he manages both the strategic market and marketing for the pharmaceutical industry. Neil has spent all his working life entrenched in the pharmaceutical industry from active research, sales and business development through to strategic marketing. Outside of work Neil enjoys rugby, cycling and spending time with his family.

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