ISPE

SEPTEMBER 10, 2023

These long global approval timelines complicate supply chain management by delaying innovations that improve quality assurance and by increasing the potential for supply interruptions and shortages that impact patient access to products.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98

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. 2 October 2019. 11 September 2019. 6 November 2019.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 27, 2022

In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. ChromaCon 2019. Figure 1 shows a typical block flow sequence of unit operations. 1 Moumné, L., Marie, and N. 8 Wetter, C., Chorley, C. del Canto, J.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Published November 2019. Published November 2019.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published November 2019. link] This novel approach to Module 2 uses a structure that shows how enhanced process knowledge, product understanding, and risk assessments are linked to the control strategy. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 15, 2023

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 24 September 2019. Process Intensification in the Biopharma Industry: Improving Efficiency of Protein Manufacturing Processes from Development to Production Scale Using Synergistic Approaches.”

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52