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. 3 (2020):e2970. Nature Communications 12, 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

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. Journal of Pharmaceutical Sciences 109 (2020):1427–1438.

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. October 2020. and the impact on supply resiliency. Burke, S.,

Documentation 52

Documentation FDA Packaging Communication 52

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. Scope The scope of the assessment was for country approvals received in the calendar years 2018–2020.

Documentation 98

Documentation Process Improvement Packaging Pharmaceutical Companies 98