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JANUARY 9, 2023

Background and Drivers One of the reasons GAMP guidance has always been successful is that it has always sought to accurately reflect current, good IT and software engineering practices, based on input from experienced IT, automation, and software practitioners. link] 4 International Society for Pharmaceutical Engineering.

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SEPTEMBER 11, 2023

Trudy Patterson Mon, 09/11/2023 - 06:10 Features September / October 2023 Air Speed Qualification: At Working Position or Working Level? 3 Lastly, the WHO published the new guideline under their framework in January 2023 as Annex 2. Published 2 February 2015. 5 , 6 From his research, the 0.45 Published 2022.

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MAY 11, 2023

Enhanced Intervention Detection in Aseptic Fill Using AI/ML Trudy Patterson Thu, 05/11/2023 - 10:32 Technical May / June 2023 Enhanced Intervention Detection in Aseptic Fill Using AI/ML Michelle Vuolo Christoph Koeth Robert J. Published January 2011. 3–7 January 2022. Pharmaceutical Technology 41, no.

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MAY 9, 2023

Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Trudy Patterson Tue, 05/09/2023 - 09:34 Features May / June 2023 Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Scott Fotheringham, PhD 1 May 2023 North Carolina’s Research Triangle is the largest of its kind in the US.

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MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C.

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SEPTEMBER 8, 2023

The scope includes innovations in modalities, modes of delivery and administration of medicines, pharmaceutical manufacturing and analytical technology, and digital transformation. The survey launched in April 2023 and is still open ! The survey consists of three parts, with the option to respond to all or any of the parts.

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JANUARY 8, 2023

We continue our discussion from previous Pharmaceutical Engineering® articles about the AI maturity model 6 and the AI governance and QA framework. Pharmaceutical Engineering 42, no. Pharmaceutical Engineering 42, no. link] 8 International Society for Pharmaceutical Engineering. Lochbronner. “AI

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MARCH 7, 2023

For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come. The exact data requirements are dependent on the pharmaceutical product. 8 (2022): 4715–4731.

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MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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MARCH 29, 2023

A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. 3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

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JANUARY 9, 2023

Trudy Patterson Mon, 01/09/2023 - 12:20 Features January / February 2023 Using Technology for Continuous Process Verification 4.0 Hayes Marc Ramoneda Rueda 1 January 2023 In this article, potential Pharma 4.0™ ™ World” article published in the May–June 2022 issue of Pharmaceutical Engineering ® .

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MARCH 15, 2023

Environmental Sustainability in Biopharmaceutical Facility Design Trudy Patterson Wed, 03/15/2023 - 09:13 Online Exclusives March / April 2023 Environmental Sustainability in Biopharmaceutical Facility Design William G. Green Manufacturing for the Pharmaceutical Industry.” Pharmaceutical Technology 41, no. Washington D.C.:

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JANUARY 10, 2023

Rapid Filter or Resin Change Strategies for Biomanufacturing Trudy Patterson Tue, 01/10/2023 - 14:05 Technical January / February 2023 Rapid Filter or Resin Change Strategies for Biomanufacturing Amy C. Genetic Engineering & Biotechnology News 41, no. Dowd, PhD Rob Deitcher Brian Kelley Nina S. 5 (2021): 60–62.

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SEPTEMBER 10, 2023

An Evaluation of Postapproval CMC Change Timelines Trudy Patterson Sun, 09/10/2023 - 11:22 Features September / October 2023 An Evaluation of Postapproval CMC Change Timelines Rob Harris, PhD Meike Vanhooren Kara Follmann, PhD Beth Kendsersky Timothy J.N. WHO Expert Committee on Specifications for Pharmaceutical Preparations.”

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