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Innovation and Continuous Improvement in Pharmaceutical Manufacturing
| Contributor(s):: Ajaz Hussain (Chairperson) Raafat Fahmy (CVM), William Bargo (CVM), Robert Coleman, Robert (ORA), Elise Murphy (ORA), Frank Holcombe Jr (CDER), Chris Watts (CDER), See Lam (CDER), Jon Clark (CDER), Christopher Joneckis (CBER), John Dietrick (CDER), Diana Kolaitis (ORA), Vilayat Sayeed (CDER), Mai Huynh (CVM), Norman Schmuff (CDER), Andrew Chang (CBER)
The PAT Team and Manufacturing Science Working Group Report: A Summary of Learning, Contributions and Proposed Next Steps for Moving towards the "Desired State" of Pharmaceutical Manufacturing in the 21st Century
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A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative
| Contributor(s):: Ajaz S. Hussain
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Quality & Regulatory Solutions for PAT in Continuous Manufacturing
| Contributor(s):: Gabriella Dahlgren, Kevin A. Macias, Antonio R. Moreira, Duncan R. Thompson, Christoph Herwig, Robert Dream
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy with continuous manufacturing (CM) because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. This article discusses quality and...
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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities
| Contributor(s):: Geng Tian
Continuous manufacturing (CM) of drug substances and drug productsProcess modeling and simulation (M&S) for CM at FDACM research highlightsOpportunities of CM for generic drug productsPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing -...
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The Regulatory Landscape Regarding Continuous Manufacturing
| Contributor(s):: Adam Fisher
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Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing
| Contributor(s):: Riley C. Myers
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USP Workshop on Identifying and Addressing Barriers to Continuous Manufacturing Adoption
Forum › defaultsection › general
On July 18 and 19, over 150 professionals gathered in Rockville, MD and virtually to identify and address the barriers to adoption of pharmaceutical continuous manufacturing (PCM). Informative...
https://cmkc.usp.org/forum/defaultsection/general/29
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Why We Need Continuous Pharmaceutical Manufacturing and How to Make It Happen
| Contributor(s):: Clive Badman, Charles L.Cooney, Alastair Florence, Konstantin Konstantinov, Markus Krumme, Salvatore Mascia, Moheb Nasr, Bernhardt L. Trout
We make the case for why continuous pharmaceutical manufacturing is essential, what the barriers are, and how to overcome them. To overcome them, government action is needed in terms of tax incentives or regulatory incentives that affect time.
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The Changing Face of Process Development & Chemical Manufacturing - A View from the Regulators on Continuous Manufacturing
| Contributor(s):: Wiles, Charolotte
Industry wide there is a drive for resource efficiency and flexibility, to adapt quickly in what is increasingly becoming a volatile, changing marketplace. As the ‘patent cliff’ looms for many high-volume API’s, there is also a shift away from blockbusters towards lower volume, higher potency...
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The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)
Guideline aims to harminze the approach to the eCTD to create efficiencies for reviewers and decrease the rejection rate for drug applications.
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The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing
| Contributor(s):: Adam C Fisher, Mark-Henry Kamga, Cyrus Agarabi, Kurt Brorson, Sau L Lee, Seongkyu Yoon
There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream and downstream processes has the potential to...
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Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.
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Recent progress in continuous manufacturing of oral solid dosage forms
| Contributor(s):: Vanhoorne, Valérie, Vervaet, Chris
Continuous drug product manufacturing is slowly being implemented in the pharmaceutical industry. Although the benefits related to the quality and cost of continuous manufacturing are widely recognized, several challenges hampered the widespread introduction of continuous manufacturing of drug...
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Regulatory and Quality Considerations for Continuous Manufacturing
| Contributor(s):: Allison, Gretchen, Cain, Yanxi Tan, Cooney, Charles, Garcia, Tom, Bizjak, Tara Gooen, Holte, Oyvind, Jagota, Nirdosh, Komas, Bekki, Korakianiti, Evdokia, Kourti, Dora, Madurawe, Rapti, Morefield, Elaine, Montgomery, Frank, Randolph, William, Robert, Jean-Louis, Rudd, Dave, Nasr, Moheb, Zezza, Diane
This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including...
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Raman Spectroscopy
Standard highlights the use of Raman spectroscopy to ensure successful application for measuring pharmaceutical products.
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Quality Risk Management
Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.
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Process Control of Drug Product Continuous Manufacturing Operations - a Study in Operational Simplification and Continuous Improvement
| Contributor(s):: Medendorp, Joseph, Shapally, Sreendhar, Vrieze, Derek, Tolton, Kelly
Purpose The purpose of this manuscript is to demonstrate that implementation of gravimetric measurements provides the same assurance of product quality and process control as spectroscopic measurements (1) for control of drug content in a fixed-dose combination (FDC) tablet and (2) for...
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Powder Flow
Standard explains the intricacies of powder flow.
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Pharmaceutical Quality System
Guideline acts as a combination of the previous two guidelines (Q8 and Q9), giving vontext to the concepts. A Pharmaceutical Quality System is explained for practical application across all manufacturing platforms in an effort to maintain quality.
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Points to Consider: ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
Note highlgihts major components of three ICH guidelines (Q8, Q9, Q10), demonstrating their reliance on one another in order to be successfully applied across pharmaceutical manufacturing operations.
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Powder Fineness
Standard reviews the properties of powder including fineness, providing important information for continuous manufacturing as powder is required to continuously flow through the system.
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Pharmaceutical Development
Guideline lays the foundation for developing pharmaceutical manufacturing processes, intoducing concepts such as QbD and PAT as key components of a successful pharmaceutical manufacturing operation.
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Pharmaceutical Dosage Forms
Standard highlghts aspects of pharmaceutical tablets.
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Near-Infrared Spectroscopy-Theory and Practice
Standard highlights the important components of using NIR for process and product analysis.
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Monitoring Devices - Time, Temperature, Humidity
Standard explains intricacies associated with various monitoring tools for use in process monitoring settings.