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

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies.

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.

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. Direct feedback from the US FDA on this pilot is shared in the discussion. Currently, it takes time and/or communications (e.g.,

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. Direct feedback from the US FDA on this pilot is shared in the discussion. Currently, it takes time and/or communications (e.g.,

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). Although they have been historically overlooked as a key element, raw materials are a critical component at every stage of the drug manufacturing processes.

Documentation 52

Documentation FDA Packaging Communication 52