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  1. A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing

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    09 Jun 2023 | Contributor(s): Su, Qinglin, Ganesh, Sudarshan Moreno, Mariana Bommireddy, Yasasvi, Gonzalez, Marcial, Reklaitis, Gintaras V., Nagy, Zoltan K.

    The Quality-by-Design (QbD) guidance issued by the US Food and Drug Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing practices including the adoption of continuous manufacturing. Active process control was highlighted recently as a means to improve the QbD...

  2. A Shared Vision for Pharmaceutical Development and Manufacturing in the 21st Century: Contributions of the PAT Initiative

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    28 Mar 2024 | Document | Contributor(s): Ajaz S. Hussain

  3. Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Byrn, Stephen, Futran, Maricio, Thomas, Hayden, Jayjock, Eric, Maron, Nicola, Meyer, Robert F., Myerson, Allan S., Thien, Michael P., Trout, Bernhardt L.

    We describe the key issues and possibilities for continuous final dosage formation, otherwise known as downstream processing or drug product manufacturing. A distinction is made between heterogeneous processing and homogeneous processing, the latter of which is expected to add more value to...

  4. Adequacy and Verifiability of Pharmaceutical Mixtures and Dose Units by Variographic Analysis (Theory of Sampling) - A Call for a Regulatory Paradigm Shift

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Esbensen, Kim H, Román-Ospino, Andrés D., Sanchez, Adriluz, Romañach, Rodolfo J.

    In spite of intense efforts in the last 20 years, the current state of affairs regarding evaluation of adequacy of pharmaceutical mixing is at an impressive standstill, characterized by two draft guidances, one withdrawn, and the other never approved. We here analyze the regulatory, scientific...

  5. An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US

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    20 Nov 2024 | Peer-reviewed journal | Contributor(s): Adam C. Fisher, William Liu, Andreas Schick, Mahesh Ramanadham, Sharmista Chatterjee, Raphael Brykman, Sau L. Lee, Steven Kozlowski, Ashley B. Boam, Stelios C. Tsinontides, Michael Kopcha

    Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and...

  6. Analytical Procedure Development

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    09 Jun 2023 | Document

    Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.

  7. Analytical Validation

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    09 Jun 2023 | Document

    Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.

  8. Continuous Manufacturing in the Pharmaceutical Industry: Enhancing Drug Production

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    23 Jul 2024 | Website | Contributor(s): Timmerman, Siebe

    A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug...

  9. Continuous Manufacturing of Drug Substances and Drug Products

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    09 Jun 2023 | Document

    Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.

  10. Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities

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    20 Nov 2023 | Workshop | 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 -...

  11. Continuous manufacturing via hot-melt extrusion and scale up: regulatory matters

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Mohammed Maniruzzaman, Ali Nokhodchi

    Over recent decades, HME techniques have appeared as an innovative manufacturing platform for various pharmaceutical applications. HME has been successfully applied to develop multiple drug delivery systems for various applications (e.g., solubility enhancement, sustained release, taste masking,...

  12. Continuous manufacturing – the Green Chemistry promise?

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Klavs F. Jensen

    Continuous manufacturing and Green Chemistry, are two promising approaches to synthesis with underutilized potential that are gaining traction by the wider pharmaceutical community. We review Green Chemistry advances resulting when transitioning to continuous manufacturing with focus on Green...

  13. Continuous manufacturing: A changing processing paradigm

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    09 Jun 2023 | Magazine | Contributor(s): Randi Hernandez

  14. Continuous manufacturing: Changing the paradigm in the pharmaceutical manufacturing sector

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    23 Sep 2024 | Magazine | Contributor(s): Indu Bhushan

    The author explains how continuous manufacturing is reshaping pharmaceutical production

  15. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

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    09 Jun 2023 | Document

    Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.

  16. Electric Common Technical Document

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    09 Jun 2023 | Document

    This work establishes the requirements and guidelines for submitting an eCTD to ensure consistency in applications.

  17. Embracing continuous manufacturing in the pharmaceutical industry

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    03 Jun 2024 | Website | Contributor(s): Joelle Anselmo

    "Drugmakers have been slow to adopt the production process, which experts say can streamline operations, boost data quality and reduce time to market."

  18. Future Supply Chains Enabled by Continuous Processing - Opportunities and Challenges

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Jagjit Singh Srai, Markus Krumme, Mauricio Futran, Clive Badman, Craig Johnston

    This paper examines the opportunities and challenges facing the pharmaceutical industry in moving to a primarily “continuous processing”-based supply chain. The current predominantly “large batch” and centralized manufacturing system designed for the “blockbuster” drug has driven a slow-paced,...

  19. Global Regulatory Landscape

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Matsuda, Y

    Continuous manufacturing (CM) of pharmaceuticals is a rapidly growing approach in the production of active pharmaceutical ingredients and finished products. The European Medicines Agency, the US Food and Drug Administration, and the Pharmaceuticals and Medical Devices Agency have independently...

  20. Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients

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    09 Jun 2023 | Document

    Guideline highlgihts important aspects of manufacturing API.

  21. Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

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    09 Jun 2023 | Document

    This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has...

  22. In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Li, Hanlin Li, Nir, Ishai, Hermans, Andre, Fahmy, Raafat, Lu, Xujin, Biba, Edmond, Coutant, Carrie A.

    As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug productmanufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability inCM. As such, the CM Working Group of the New Advancements in...

  23. Innovation and Continuous Improvement in Pharmaceutical Manufacturing

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    28 Mar 2024 | Document | 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

  24. Integrated continuous manufacturing in pharmaceutical industry: current eolutionary steps toward revolutionary future

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    09 Jun 2023 | Peer-reviewed journal | Contributor(s): Nada A Helal, Ola Elnoweam, Heba Abdullah Eassa, Ahmed M Amer, Mohamed Ashraf Eltokhy, Mohamed A Helal, Heba A Fayyaz, Mohamed Ismail Nonou

    Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM....

  25. Light Diffraction Measurement of Particle Size

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    09 Jun 2023 | Document

    Standard explain phenomena associated with light interaction with powder.