Blog Feed Post

FDA Moves Toward a Quality-Centric Regulatory System

The FDA’s Groundbreaking Strides Toward a Quality-Centric Regulatory System

Two famous pharmaceutical industry quotes encapsulate industry thinking and the push for progress in recent years. Upon launching Pharmaceutical cGMPs for the 21st Century – a Risk-Based Approach, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), shared the following vision: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight.”

Gerry Migliaccio, former head of global quality at Pfizer, once notoriously stated, “We produce six sigma products with three sigma processes.” Gerry was referring to the fact that the pharmaceutical industry’s over-reliance on compliance-based inspection to achieve quality is a very ineffective way to do business and that most other industries, even those in heavily regulated environments such as nuclear and aviation, moved away from this way of working many years ago.

Before exploring FDA action to achieve the outlined vision and address the great challenge shared by Mr. Migliaccio, it is important to recognize some of the primary pharmaceutical quality issues the industry and regulatory community have been wrestling with in recent years:

  • Treatment of all products equally, resulting in a disproportionate amount of regulatory attention devoted to low-risk products, diverting needed resources for high-risk products.
  • Unacceptably high levels of product recall and defect reporting that is too frequently rooted in defects in product and process design.
  • Shortages of critical drugs in recent years are also often the result of ineffective product and process design and the lack of effective quality management systems.
  • Inspections are not well connected to knowledge gained from product review and applications.
  • Because current FDA practice “locks in” a process before it is fully optimized, post-approval supplement submission levels are substantially higher and are a burden to both the FDA and industry.
  • Product review is often conducted based on pre-marketing data from exhibit or clinical batches. There may be significant differences between these data and the conditions of commercial production.

So, within an environment of increased drug product complexity, the need for greater numbers of different specialty drugs to treat smaller patient populations, and more complex drug product supply chains, the industry and the regulatory community still:

  • Do not understand their products and processes to the degree necessary
  • Are hampered by a compliance-based regulatory framework that does not allow easy adjustment of processes based on the ongoing accumulation of product and process understanding
  • Operate within the framework of all products, regardless of risk, essentially being treated equally

To move toward a system that ultimately regulates quality rather than compliance, the FDA and other regulatory bodies around the world are working to move to a system that considers drug product risk in a strategic manner. As other heavily regulated industries have already recognized, all products and situations should not be treated equally. Rather, regulatory resources need to be more heavily focused on the greatest areas of risk.

To achieve a risk-based construct, CDER’s new Office of Pharmaceutical Quality (OPQ) formulated the New Inspection Protocol Project (NIPP) incorporating five priorities: regulatory science, globalization, safety and quality, smart regulation, and stewardship.

NIPP will strive to differ from regulatory and inspection practices that have been in place for decades by using informatics, internal analysis, and other digital tools to prepare for and steer inspections. By utilizing data and predictive analytics, NIPP will allow the development of algorithms to reveal product quality challenges and facilitate inspections that concentrate on high-risk, inconsistent processes and products. A key aim of the NIPP is to focus attention and resources on high-risk processes and products so that, ultimately, quality improvements can be identified and made more quickly.

Organizationally, the NIPP consists of three subgroups: Pre-approval Inspection Protocol(s) subgroup, the Surveillance Inspection Protocol(s) subgroup, and the For Cause Inspection Protocol(s) subgroup. These subgroups will mine regulatory data to improve the FDA’s understanding of processes and approaches that produce quality products.

The FDA is using informatics as the cornerstone of NIPP. A database will evaluate the history of a given pharmaceutical manufacturing site for the following eight facility risk factors:

  1. Process
  2. Research
  3. Analytical Methods
  4. Sterility/Microbiology
  5. Inspections
  6. APIs and Excipients
  7. Chemistry Manufacturing and Controls (CMC), and
  8. Policy/Enforcement Actions

An algorithm will calculate the findings from the historical data and integrate them with product and facility risk factors to calculate a site ranking. Ultimately, higher-risk pharmaceutical manufacturing inspection sites will be identified and given priority resources.

To increase regulatory efficiency, based on the knowledge garnered from the NIPP inspections, the FDA can make more informed decisions on frequency of inspections, prioritization of inspections, and more effective pre-inspection planning so that time on site is optimized as fully as possible and hours are reduced as much as possible.

In the end, NIPP’s and OPQ’s goals are to strive for inspections that determine quality and more closely scrutinize risk-intensive products and operations, rather than inspecting for adherence to SOPs and other such regulatory criteria that may or may not lead to higher-quality products that reduce patient risk.

Interested in Process Validation in the Era of Expedited Approval Drugs? Download the White Paper from BioTechLogic

The post FDA Moves Toward a Quality-Centric Regulatory System appeared first on B2B Labs.

Read the original blog entry...

More Stories By Ben Bradley

Known for wearing plaid and sweater vests before they were popular, Ben Bradley is managing director of Macon Raine, Inc. (www.maconraine.com) - a management consulting, marketing and demand generation firm for technology organizations. He is a graduate of the University of Iowa and was a member of the undergraduate Iowa Writer’s Workshop. His interests include the intersection of technology and marketing. Because he was never very good at sports and doesn’t have many hobbies, his primary interests include the role of marketing on internal technology adoption, micro-finance, military uses of technology and media, self-organizing networks, network and physical security, collaboration and groupware. He frequently lectures his children on a variety of topics. Bradley was raised in Wheaton, Illinois and currently resides in Glen Ellyn, Illinois with his wife, two children and a purebred Latvian Goathound named Stella.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...