ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S. 3 , 27 Advantages POD increases manufacturing flexibility, speed, and consistency.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

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. Table 1: Appendices and drug substance Module 3 required sections * Corresponding Quality Overall Summaries (QOS) sections 2.3.S.1,

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

JULY 6, 2023

In recent years, global pharmaceutical supply chains, still based on traditional batch- and intermediates-based manufacturing, were overwhelmed by their own vulnerabilities and inefficiencies, and were stressed to the brink of failure as a result of the SARS-COV-2 pandemic. In 2021, CONTINUUS Pharmaceuticals secured a$69.3

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 8, 2023

Main section chapter 7.12 Main section chapter 7.12 The pharmaceutical industry is increasingly relying on such innovative technologies to automate many functions previously performed by humans. Table 1: Regulation of AI and corresponding GAMP ® 5 guidance that covers a general description of the AI system.

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Documentation 52

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Risk-Based Manufacture of Pharmaceutical Products. Trudy Patterson. Wed, 10/26/2022 - 16:08.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. Sixth Assessment Report: Climate Change 2021: The Physical Science Basis.” Finalized 9 August 2021. C global warming scenario.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

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.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

3 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. link] 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.” The authors propose using Module 2.3

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Documentation Dosage Packaging Communication 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Common Technical Document [CTD] sections).

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Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 12, 2022

Director, Office of Pharmaceutical Quality Operations. I'd like to concur that data integrity issues and poor data governance can be found in any sector of pharmaceutical manufacturing. Director, Office of Pharmaceutical Quality Operations. There is a lot of good engineering out there. Panel Participants. Alonza Cruse.

FDA 52

FDA Documentation Communication 52

ISPE

SEPTEMBER 8, 2023

The scope includes innovations in modalities, modes of delivery and administration of medicines, pharmaceutical manufacturing and analytical technology, and digital transformation. Addressing divergence in global regulatory expectations is imperative to improve the advancement of pharmaceutical and technological innovation.

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FDA Dosage Documentation Communication 52

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AUGUST 30, 2022

The pharmaceutical manufacturing supply chain starts with the raw materials, which are needed to ensure drug availability for patients. The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines contain information regarding regulatory requirements for raw materials.

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Documentation FDA Packaging Communication 52

ISPE

JANUARY 10, 2023

Section 101 of the Defense Production Act of 1950 was extended by Executive Order 13911 in 2020 to Respond to the Spread of COVID-19. Genetic Engineering & Biotechnology News 41, no. Presented at Well Characterized Biotechnology Pharmaceutical (WCBP) Conference. Pharmaceutical/Biotech Man. 5 (2021): 60–62. 2 Hughes, P.

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Packaging FDA Communication Vaccines 52