Building the Foundation for Continued Process Verification with Industry 4.0 Manufacturing Analytics

Building the Foundation for Continued Process Verification with Industry 4.0 Manufacturing Analytics

04/17/2018, 11:30 AM - 12:15 PM

Technical Conference Stage 2, Booth 1177, Exhibit Hall

Language:
English

The quest by leading pharmaceutical and life sciences companies to achieve Continued Process Verification has begun in earnest. Originally a guidance issued by the U.S. Food and Drug Administration in 20011 – and subsequently by the European Medicines Agency in 2014 – CPV is intended to demonstrate intentional control during any particular point in a commercial manufacturing process and an integral part of the process validation lifecycle. CPV ensures that a validated process remains in the validated state throughout the manufacturing process. A key part of risk management for industry manufacturers, CPV represents a formal approach to proactively collecting, analyzing and utilizing process performance data to demonstrate initial and ongoing process control to deliver consistent product quality. With Stage 3 of the Guidance specifying statistical process control (SPC) and Process Capability analysis as its foundation, CPV is not simply monitoring production processes, it's about improving them. The ultimate goal is active process understanding and, if needed, proactive intervention. It is intended to inform manufacturers of process health – ideally in as close to real time as possible/practical – so changes to the process can be effected in order to keep it in the "sweet spot" and avoid producing off-specification, and therefore potentially ineffective or worse, dangerous poor-quality product. Ultimately, there are two compelling forces driving pharmaceutical and life sciences manufacturers to implement CPV. The first, and most obvious, is regulatory. The latest research from analyst firm LNS Research and MESA International confirms regulatory requirements for quality management are by far the biggest concern for pharmaceutical and life sciences manufacturers. And even if addressing the regulatory aspect weren't reason enough to implement CPV, the second – competitive pressures – delivers an equally-compelling economic rationale. The pressures to eliminate inefficiencies and increase process reliability and performance are paramount business-success drivers for the modern pharmaceutical and life sciences manufacturer. This confluence of driving forces – regulatory and competitive – not only makes it a strategic imperative for pharmaceutical and life sciences manufacturers to deliver on CPV, but also increases the pressure on them to select a technology approach that delivers results quickly and reliably, and is extensible as new technologies and methodologies become available. Delivering on CPV represents a unique opportunity for industry leaders to define how it is achieved given the regulatory drivers have not dictated a particular course of action. The FDA leaves the details of how CPV gets implemented to each individual manufacturer so long as it is done within the parameters of original guidance. This marks a necessary paradigm shift in manufacturing technology strategies for pharmaceutical and life sciences companies. And the shift allows companies the latitude to look external to the industry to understand how other leading manufacturers have been delivering the equivalent of CPV. Regardless, any approach must also leverage a manufacturer's existing infrastructure, be fully implement in weeks (not months or years), be quickly assimilated and understood at all level of the organization (operators to executives), easily scale to cover the enterprise, and deliver quantifiable results immediately. The clear advantage for pharmaceutical and life sciences manufacturers is the available proven implementation and execution blueprints provided by recognized leaders from many of the industry's top suppliers (chemical and specialty chemical companies). They have greatly reduced the overall risk by codifying the technology requirements necessary for success – direct data source connectivity, universal analytics layer, robust foundational analytics (SPC), and defined real-time role-specific visualization – that conveniently fit seamlessly in an existing, validated environment. Using real-world case studies, this session will examine how leading pharmaceutical companies have leveraged that proven approach to deliver CPV Stage 3, related practical steps and best known methods, and the return on the investments realized.

Contributors

  • Peter Guilfoyle

    Speaker

    Vice President

    Northwest Analytics

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. Attendees will learn how their peers are leveraging existing technologies and infrastructures to achieve CPV Stage 3. 2. Attendees will take away key learnings, best known methods and practical steps to acheive CPV Stage 3. 3. Attendees will understand why analytics are foundational to CPV Stage 3 and various approaches that fit within the FDA and EMA CPV Guidelines.

Categories

  1. Track
    Continuous Manufacturing

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