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. BioPharm International. iSpeak blog.

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. Getting More from Facilities. 8 Wetter, C.,

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

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

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. Common Technical Document [CTD] sections).

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 15, 2023

Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). 24 September 2019. 7 An integrative (vs. 7 An integrative (vs. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 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). Finally, the DP is packaged in a suitable container to ensure continued quality. Published November 2019. and the impact on supply resiliency. 9 Lo Surdo, J. Cauchon, C.

Documentation 52

Documentation FDA Packaging Communication 52