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4 New Control Approaches to Enable Quality Assurance and Process Capability
Pages 36-47

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From page 36...
... require modern process-control approaches to support methods, and advanced process control are highlighted, quality assurance and process capability, particularly for and technical and regulatory challenges associated with complex processes and products. In the pharmaceutical the technologies and some recommendations for overindustry, control strategy is defined as a "planned set of coming them are also provided.
From page 37...
... Off-line sensors tend to provide the more detailed infor As pharmaceutical manufacturing processes be- mation about the chemical and physical characteristics of come more integrated, their complexity as systems will materials that helps to build that understanding. However, increase; this is the case for advanced manufacturing these analytic tools do not provide real-time results and so applications, such as continuous manufacturing and in- are deployed in off-line configurations to obtain data that tensified operations (Huang et al.
From page 38...
... A soft sensor is one such applicaon a single unit operation. Because they typically do not tion; it consists of a model that draws on multiple sensor measure quality attributes, such sensors alone cannot en- measurements as inputs to predict an unmeasurable proable active process control of product quality and cannot cess variable.
From page 39...
... For example, using Raman spectroscopy as increase scientific understanding, estimate state variables part of a glucose-feedback controller should not be seen of a process, predict process behavior, and drive control differently from using a classic pH meter as part of a pH- strategies.  Models can be created by data-mining, by control strategy.  The confusion might be caused by the using first principles, or by combining data-driven and practice in the pharmaceutical industry of using regula- mechanistic models (hybrid models) (Romero-Torres et tory language when describing technology (for example, al.
From page 40...
... lations, however, are often too computationally time-consuming to provide answers in real time and might not be Models for Advanced Process Control  able to capture all the underlying complex phenomena or to account for stochastic behavior in a system. For those Models are at the heart of advanced process control reasons, data-driven or hybrid models that incorporate (APC)
From page 41...
... . One potential in • Identify and diagnose a process fault that requires novation that will change process development in the next timely intervention. 5–10 years is the use of digital twins that are developed • Identify a performance degradation that requires with hybrid modeling approaches, including AI methods.
From page 42...
... As the industry Technical Challenges progresses from traditional batch operation to integrated process trains, as is the case in continuous manufacturing, The innovations described above entail many technithe dynamics of the successive unit operations need to be cal challenges. The main challenges in adopting models closely linked.
From page 43...
... Ensuring these technologies. First, few experts in data analytics and system integrity will also be a key requirement. Similarly, system modeling are also knowledgeable in pharmaceu- the robust operation of highly intensified unit operations tical manufacturing.  Data analytics and system model- or sequences of operations can be achieved only through ing constitute a specialty in themselves that requires ad- active process control inasmuch as intensification by its vanced knowledge of statistics and mathematics.
From page 44...
... Nevertheless, processes continuous units, but the final process output stream is with low capabilities and predictabilities can benefit trecontinuous. Flexibility in the interpretation of what con- mendously from better control mechanisms to increase stitutes a lot or batch in the context of continuous manu- the process reliability that directly affects "supply-abilifacturing has been allowed, and the committee finds that ty." Depending on the manufacturing frequency, cost of similar flexibility should be allowed in the interpretation goods, process complexity, and available infrastructure, of a batch with hybrid production systems that would be a company can make business decisions about what level independent of the operational batches that are internal to of observability and control should be built into its prothe hybrid process.
From page 45...
... • Inspector competences. The increased reliance REFERENCES   on advanced control strategies -- including fault detection and mitigation strategies and condition-based monitor- Arnold, R
From page 46...
... Presentation at Workshop on Innovations in etry Measurements of the Fab Fragment of NISTmAb. Pharmaceutical Manufacturing, February 27.
From page 47...
... Presentation at Virtual Workshop on Technical and Regulatory Barriers to Innovations in Pharmaceutical Manufacturing, June 2. https://www.nationalacademies.org/event/06-02-2020/ docs/D6844C91F035D812C8A191DE35B439B2B6C0 480E7D97 (accessed August 22, 2020)


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