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. Genetic Engineering and Biotechnology News. 5 October 2022.

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. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

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. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements.

Documentation 52

Documentation Dosage Packaging Communication 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. Combining the incremental process improvements previously mentioned results in an optimized facility, with the adjusted block flow shown in Figure 5.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

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. and the impact on supply resiliency. 11 Ahluwalia, K., Abernathy, J.

Documentation 52

Documentation FDA Packaging Communication 52