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. 1 (2021):48. 6540 (2021):341–42. 1 (2021):7200.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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.

Documentation 52

Documentation FDA Communication Packaging 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. 16 (20 September 2021): 9026–41. Figure 1 shows a typical block flow sequence of unit operations. 1 Moumné, L., Marie, and N. Pharmaceutics 14, no. Shimizu, N.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The authors propose using Module 2.3 8] The proposed comprehensive QOS fulfills these conditions.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Published 15 November 2021. This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. For purpose of illustration used throughout this article, labels have been assigned to each CQA. The authors propose using Module 2.3 8] The proposed comprehensive QOS fulfills these conditions.

Documentation 52

Documentation Dosage Packaging Communication 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. 5 (September/October 2021). and the impact on supply resiliency.

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). 14–25 (November–December 2021). Chemical Engineering and Processing 171 (2022): 108727. www.sciencedirect.com/science/article/pii/S0255270121004116 18 NHS. 25 February 2021.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52