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

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. Cone-bottom reaction vessels can provide the turndown required to process a variety of scales and handle different reactions. 16 (20 September 2021): 9026–41.

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

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. 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). 5 (September/October 2021).

Documentation 52

Documentation FDA Packaging Communication 52