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. Nature Communications 12, no. Biotechnology Progress 36, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., For purpose of illustration used throughout this article, labels have been assigned to each CQA. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. Currently, it takes time and/or communications (e.g., For purpose of illustration used throughout this article, labels have been assigned to each CQA. Direct feedback from the US FDA on this pilot is shared in the discussion.

Documentation 52

Documentation Dosage Packaging Communication 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. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.

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. US Food and Drug Administration.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. and the impact on supply resiliency. 11 Ahluwalia, K., Abernathy, J.

Documentation 52

Documentation FDA 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). 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