ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). and Chair of the ISPE Drug Shortages Team. This article outlines these initiatives.

Documentation 91

Documentation 91

ISPE

NOVEMBER 1, 2022

iSpeak Blog. The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality.

FDA 98

FDA Insurance Chemotherapy Documentation 98

ISPE

SEPTEMBER 11, 2023

There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the advantages of advanced and decentralized manufacturing techniques. In particular, DM and POC manufacturing models are considered a natural fit to produce many cell and gene therapies.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52