2004 Documentation Dosage Process Improvement 
ISPE
SEPTEMBER 11, 2023
POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. September 2004. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.” “Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” September 2004. 2 (1 May 2005).
ISPE
AUGUST 30, 2022
The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.
Expert insights. Personalized for you.
52 
Let's personalize your content