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 (2022):593–607. October 2022. 1 (2021):48.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 27, 2022

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Crouvezier.

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

ISPE

MARCH 29, 2023

This article summarizes an alternate and more functional way to format the QOS presented in Module 2.3. 2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). ISPE Regulatory. Langer, and R.

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. 2022) [link] 8 Kendsersky, B., September–October 2022) 9 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 1 (January–February 2022). ISPE Regulatory. Langer, and R.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 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). Reader note: This article was originally submitted to Pharmaceutical Engineering® in January 2022.

Documentation 52

Documentation FDA Packaging Communication 52