Pharmaceutical Technology Quality and Regulatory Sourcebook
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Facilitating Biopharma Continuous Manufacturing
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Facilitating Biopharma Continuous Manufacturing
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Pharmaceutical TechnologyPharmaceutical Technology, Regulatory Sourcebook, March 2022
Volume 2022 eBook
Issue 1
Pages: 52-54
USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.
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Manufacturers, regulators, and other industry organizations are aiming to advance biopharmaceutical continuous manufacturing and to connect upstream and downstream into fully continuous processes. The United States Pharmacopeial Convention (USP), a nonprofit organization known for developing standards for quality, is actively involved in facilitating implementation of continuous manufacturing in the bio/pharmaceutical industry. Pharmaceutical Technology spoke with John Kokai-Kun, director, External Scientific Collaboration at USP about these efforts.
Read “Facilitating Biopharma Continuous Manufacturing” in Pharmaceutical Technology’s Quality and Regulatory Sourcebook Ebook.
Article details:
Pharmaceutical Technology
eBook: Quality and Regulatory Sourcebook
March 2022
Pages: 52-54
Citation
When referring to this article, please cite it as J. Markarian, “Facilitating Biopharma Continuous Manufacturing,” Pharmaceutical Technology’s Quality and Regulatory Sourcebook eBook (March 2022).
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Common FDA 483 Observations for Combination Products
Facilitating Biopharma Continuous Manufacturing
In-Use Testing of Cleanroom Garments
How a Lack of Critical Thinking is Hindering Regulatory Compliance
A Method Validation Framework for Combination Products
Contextualizing Computer Validation
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
Remote Inspections - Lessons Learned
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