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Innovation and Continuous Improvement in Pharmaceutical Manufacturing
Document | 28 Mar 2024 | 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
Document | 28 Mar 2024 | Contributor(s):: Ajaz S. Hussain
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The Regulatory Landscape Regarding Continuous Manufacturing
Document | 17 Aug 2023 | Contributor(s):: Adam Fisher
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Mitigating Regulatory Challenges to Adoption of Advanced Manufacturing
Document | 17 Aug 2023 | Contributor(s):: Riley C. Myers
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The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - M4Q(R1)
Document | 09 Jun 2023
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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Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Document | 09 Jun 2023
Document highlights the product lifecycle and the various considerations for maintaining consistent quality through both shelf life and entire lifecycle.
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Raman Spectroscopy
Document | 09 Jun 2023
Standard highlights the use of Raman spectroscopy to ensure successful application for measuring pharmaceutical products.
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Quality Risk Management
Document | 09 Jun 2023
Guideline establishes the environment surrounding risk detection and mitigation in order to maintain high quality pharmaceutical products.
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Powder Flow
Document | 09 Jun 2023
Standard explains the intricacies of powder flow.
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Pharmaceutical Quality System
Document | 09 Jun 2023
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
Document | 09 Jun 2023
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
Document | 09 Jun 2023
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 Dosage Forms
Document | 09 Jun 2023
Standard highlghts aspects of pharmaceutical tablets.
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Pharmaceutical Development
Document | 09 Jun 2023
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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Near-Infrared Spectroscopy-Theory and Practice
Document | 09 Jun 2023
Standard highlights the important components of using NIR for process and product analysis.
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Monitoring Devices - Time, Temperature, Humidity
Document | 09 Jun 2023
Standard explains intricacies associated with various monitoring tools for use in process monitoring settings.
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Light Diffraction Measurement of Particle Size
Document | 09 Jun 2023
Standard explain phenomena associated with light interaction with powder.
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Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
Document | 09 Jun 2023
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...
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Good Manufacturing Practice Guide for Active Pharmacetuical Ingredients
Document | 09 Jun 2023
Guideline highlgihts important aspects of manufacturing API.
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Electric Common Technical Document
Document | 09 Jun 2023
This work establishes the requirements and guidelines for submitting an eCTD to ensure consistency in applications.
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Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Document | 09 Jun 2023
Guideline establishes reuqirements for the synthesis/production of API in primary pharmaceutical manufacturing.
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Continuous Manufacturing of Drug Substances and Drug Products
Document | 09 Jun 2023
Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.
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Analytical Procedure Development
Document | 09 Jun 2023
Guideline provides a foundation for consistent development of analytical methods to maintain precision and accuracy, contirubting to the maintenance of quality products.
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Analytical Validation
Document | 09 Jun 2023
Guideline establishes the requirements for validationg analytical methods, ensuring consistency in the routeine measurements of pharmaceutical products and their intermediates.