ISPE

MARCH 8, 2023

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s culture of quality. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes.

Documentation 52

Documentation Communication 52

ISPE

OCTOBER 1, 2022

Versatile, modular plants are the process industry's response to constantly changing market requirements, and the pharmaceutical industry is no exception. Flexible technical solutions for the automation of modular plants are in high demand to ensure the consistent implementation of modular plant engineering. State/Province.

Packaging 52

Packaging Communication 52

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Dosage 84

Dosage Packaging Compounding Labelling 84

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 11, 2023

This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 23, 2023

As the momentum grows in the rollout of various digital tools to aid verification and validation in the pharmaceutical space there are many questions in relation to the correct application of the True Copy process to digital evidence within protocols in a paperless validation system. This would satisfy the requirement under PICS section 8.11

Documentation 98

Documentation FDA 98

ISPE

MAY 10, 2023

Sanat’s organization oversees a complex and large network of manufacturing, commercialization, and distribution operations across four different platforms of pharmaceuticals, vaccines, biologics, and animal health with over 20,000 employees in over 22 countries. Articles can be 400 to 1,000 words. Please submit to msanford@ispe.org NA NA

Vaccines 52

Vaccines 52

ISPE

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.

Documentation 52

Documentation FDA Packaging Communication 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. Complete Data Gathering.

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.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

OCTOBER 28, 2022

This article shows how automation engineers and client validation personnel were successful in navigating COVID-19 restrictions and overcoming previously held preconceptions about remote testing to meet end-user and regulatory requirements. In the pharmaceutical sector, the ISPE Good Automated Manufacturing Practice (GAMP) 1.

Communication 52

Communication Documentation FDA 52

ISPE

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. 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.

Packaging 52

Packaging FDA Communication Vaccines 52

ISPE

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. link] 6 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Documentation 52

Documentation Labelling FDA 52

ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

As digital health sits at the intersection of technical, scientific, and regulatory disciplines involving medical devices, drugs, and biologics, the successful development of novel DHTs will require significant collaboration with health care stakeholders to overcome regulatory, technical, and life-cycle management challenges.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. Section 361: Adulterated Cosmetics. Cleaning Engineering and Equipment Design.” Rao Nicole Granda Alvarez Paul T.

Method Validation 52

Method Validation Documentation Packaging Compounding 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