{"id":4920,"date":"2021-09-10T13:00:00","date_gmt":"2021-09-10T13:00:00","guid":{"rendered":"https:\/\/www.waters.com\/blog\/analytical-quality-by-design\/"},"modified":"2022-07-28T03:17:51","modified_gmt":"2022-07-28T03:17:51","slug":"analytical-quality-by-design","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/analytical-quality-by-design\/","title":{"rendered":"Reliable, Reportable Data with Analytical Quality by Design Approaches"},"content":{"rendered":"

There\u2019s a\u00a0significant\u00a0paradigm shift\u00a0and it\u2019s\u00a0drastically changing the\u00a0way\u00a0pharmaceutical organizations and their partners\u00a0achieve reliable, reportable data.\u00a0The route to drug approval\u00a0requires\u00a0a multitude of underlying activities and factors which, if not managed carefully, can have a devastating\u00a0business\u00a0impact.\u00a0While still important, regulatory compliance alone is simply not enough\u00a0to be able to make critical\u00a0drug product related decisions.<\/p>\n

Analytical Quality by Design<\/strong>: Paradigm Shift for Method Development<\/strong><\/h3>\n

Recently, quality by design (QbD) principles for drug manufacturing, as described in the pharmaceutical development guidance (ICH Q8<\/a>), are suggested to increase the robustness of analytical methods to generate “reliable reportable data to enable such decisions.”<\/p>\n

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As a response,\u00a0new upcoming\u00a0guidance\u00a0from the\u00a0US\u00a0Pharmacopeia\u00a0called Chapter <1220>, \u201cThe Analytical Procedure Lifecycle\u201d and the\u00a0ICH Q14<\/a>, \u201cAnalytical Procedure Development,\u201d\u00a0outline and suggest how\u00a0QbD\u00a0principles can be applied for\u00a0risk-based\u00a0method development and\u00a0optimization.\u00a0Commonly referred to as Analytical Quality by Design (AQbD),\u00a0it\u00a0is more important than ever\u00a0to\u00a0implement such risk-based processes\u00a0for method development and optimization\u00a0as\u00a0the pressures of maintaining quality and ensuring patient safety continue to grow.<\/p>\n

Reliable, reportable data: the result of\u00a0<\/strong>AQbD<\/strong><\/h3>\n

Traditional\u00a0or conventional\u00a0method development\u00a0or optimization\u00a0is often\u00a0empirical,\u00a0and\u00a0the\u00a0quality of the method\u00a0is usually not assessed properly.<\/p>\n

Under\u00a0an\u00a0AQbD\u00a0approach,\u00a0the first step is to define\u00a0and document the intended purpose and required performance of the method\u00a0in the form of an Analytical Target Profile (ATP).\u00a0Once the method requirements are fully assessed,\u00a0risk assessments are performed to\u00a0determine the\u00a0right\u00a0technology capable of\u00a0meeting the ATP and what parameters, when varied and to what degree, will impact the\u00a0method\u2019s ability to meet the ATP.<\/p>\n

According to\u00a0Dr.\u00a0Stephanie Harden,\u00a0Manager of Global Pharmaceutical Business Development at Waters Corporation: \u201cHaving a thorough understanding of\u00a0how to develop robust\u00a0methods\u00a0that are fit for their intended purpose,\u00a0achieve\u00a0performance goals, and are linked to the Critical Quality Attributes\u00a0(CQA) of specific drug products\u00a0is the\u00a0new approach.<\/p>\n

\u201cThe new measure of method success is the output, or reportable result. To achieve a trustworthy result, methods\u00a0should be well-understood, undergo an upfront risk assessment,\u00a0and its performance criteria should be specified in terms of accuracy and precision in an Analytical Target Profile (ATP).<\/p>\n

\u201cThe method should also embody a control strategy designed to mitigate the identified risks and method performance trending should take place throughout the method\u2019s life. In addition, scientists also need access to easy-to-use and high-performing analytical instrumentation. Without the right analytical technologies, executing methods can prove challenging and hinder progress.”<\/em><\/p><\/blockquote>\n

According to\u00a0Dr.\u00a0Harden,\u00a0modern tools and technologies are\u00a0leading the way in the design of\u00a0robust, fit-for-purpose methods; enhancing\u00a0laboratory\u00a0efficiency, controlling\u00a0risk, and generating\u00a0reportable results that\u00a0enable\u00a0better decision-making.<\/p>\n

Recent software advancements\u00a0that enable\u00a0fully\u00a0automated Design of Experiments (DOE)\u00a0with\u00a0MS peak tracking\u00a0serve as vital tools to support\u00a0AQbD\u00a0method development and\/or optimization.\u00a0In conjunction\u00a0to\u00a0evaluating the\u00a0technology\u00a0that enables the method to meet the ATP,\u00a0modern LC technologies are\u00a0being adopted.<\/p>\n

AQbD<\/strong>: Benefits beyond reliable, reportable data <\/strong><\/h3>\n

The direct result of implementing AQbD for method development is obtaining trustworthy results from a robust method \u2013 but there is so much more! AQbD approaches not only support the development of robust methods; they promote method performance monitoring, as well as reduce the need and cost to redevelop and revalidate methods. Such risk-based approaches also increase the success rate of method validation and transfer, improve data quality, increase confidence to communicate with regulators, and reduce regulatory submission inquiries.<\/p>\n

Modern technologies and tools to support <\/strong>AQbD<\/strong> implementation<\/strong><\/h3>\n

Access additional resources to learn more about how you can leverage modern analytical tools and apply an Analytical Quality by Design approach in your laboratory:<\/p>\n