This week, the U.S. Food and Drug Administration released its Strategic Plan for Regulatory Science. The plan calls for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security. According to FDA Commissioner Margaret A. Hamburg, “It positions us to foster innovation through better science without compromising our high safety standard,” M.D.
The Strategic 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. These priority areas are:
- Modernize Toxicology to Enhance Product Safety
- Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
- Support New Approaches to Improve Product Manufacturing and Quality
- Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
- Harness Diverse Data through Information Sciences to Improve Health Outcomes
- Implement a New Prevention-Focused Food Safety System to Protect Public Health
- Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
- Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products
In this article, I would like discuss priority #3, “Support New Approaches to Improve Product Manufacturing and Quality.”
To support this priority, FDA will continue to promote what it calls “state-of-the-art manufacturing strategies,” Process Analytical Technology (PAT) and Quality-By-Design (QbD). The challenge for industry and regulators is that outsourcing may be hindering the application of PAT and QbD. In my Viewpoint article published in the current issue of Pharmaceutical Technology (you decide if it was a coincident), I discuss the issues and propose solutions and best practices to address them (See: Has Outsourcing Derailed 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. Such information would afford a sponsor company the opportunity to better and more tightly control ingredients, components, and products supplied by third parties. This control is crucial to help reduce the risk of nonconformances, CAPAs and recalls.
Technology is not the stumbling block. Today, mature technology is 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 across the global supply chain, but also would manage product safety, efficacy, and quality.
To support PAT and QbD approaches in a global and outsourced environment, companies must implement strategies to provide On-Demand Visibility across every stakeholder in their supply network.
Do you have On-Demand Visibility?
You are not alone. According to our research only 3% of industry executives said they have it.