Has Outsourcing Derailed PAT and QbD? - Pharmaceutical Technology

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Has Outsourcing Derailed PAT and QbD?
Quality management requires more effort in a complex supply chain.

Pharmaceutical Technology
Volume 35, Issue 8, pp. 134, 133

Potential solutions

This lack of visibility supports the need for the implementation of data acquisition and analytic systems and processes that can help provide on-demand visibility across a company's supply chain. Such information would afford a sponsor company the opportunity to better and more tightly control ingredients, components, and products supplied by third parties. Because brand owners are responsible for the safety, efficacy, and quality of their products, this control is crucial and can help manage and reduce the risk of nonconformances, corrective and preventive actions, and product recalls.

To address the challenges of globalization and outsourcing, companies must implement strategies to provide appropriate levels of visibility across every stakeholder in their supply network.

The willingness of partners to share information was a top issue uncovered by Axendia's research. When asked, "What are your organization's concerns regarding increased regulatory focus on global supply-chain issues?" nearly 60% said they are concerned about the willingness of suppliers to provide information. Forty-four percent are concerned about their distributors' willingness to provide information required to meet regulatory requirements.

This information would ensure that organizations can support the full genealogy and traceability of their products, from raw materials to end users. The willingness of suppliers and contract organizations to provide that information is imperative to achieving this goal. It is not enough to look at the first link in the chain. In an age when contract organizations are also outsourcing, the supply chain is even longer and more difficult to assess. Brand owners, therefore, must go further into their supply chains to assess distributors as well as suppliers to their suppliers. Such visibility would enable downstream processes (whether local, global, or outsourced) to adjust CQAs and CPPs to compensate for product characteristics.

Today, there is mature technology available to support the implementation of interconnected and interoperable systems that provide on-demand-visibility across the supply network. This level of transparency would not only support PAT and QbD approaches, but also would manage product safety, efficacy, and quality.

Daniel R. Matlis is founder and president of Axendia,

Read the full analysis in our special Outsourcing issue.


1. M. Hamburg, Testimony before the US House Subcommittee on Oversight and Investigations, Apr. 13, 2011, http://www.fda.gov/NewsEvents/Testimony/ucm250710.htm.

2. Axendia Research Report, "Achieving Global Supply Chain Visibility, Control & Collaboration in Life Sciences: Business Imperative, Regulatory Necessity," 2010, http://www.axendia.com/2010_LS_GSC.html.

[On Aug. 17, 2011], the FDA released its Strategic Plan for Regulatory Science. The Plan identifies eight priority areas of regulatory science where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. FDA’s Priority #3 is to “Support New Approaches to Improve Product Manufacturing and Quality.” To this end, FDA will continue to promote what it calls “state-of-the-art manufacturing strategies,” Process Analytical Technology (PAT) and Quality-By-Design (QbD).

Author Comment

The challenge for industry and regulators is that outsourcing may be hindering the application of PAT and QbD. As the pharmaceutical industry increases outsourcing, many brand owners have lost their ability to collect, act, and capitalize on critical quality attributes and process parameters. These data are critical to achieve PAT and QbD. This lack of visibility supports the need for the implementation of data acquisition and analytic systems and processes that can provide On-Demand Visibility across a company's supply chain.


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