PharmTech

FDA's New Process Validation Guidance: Industry Reaction, Questions, and Challenges

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation. The regulatory basis for process validation is ...
PharmiWeb

First batch of the Sputnik V vaccine produced in Belarus for validation

Moscow, February 26, 2021 – The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), Generium, a high-end Russian pharmaceutical company, and Belmedpreparaty, the leading ...
PharmTech

Process validation for continuous manufacturing processes

Although some aspects of process validation for continuous processes are the same as those for traditional batch processes, there are some unique considerations. Although some aspects of process ...
PharmiWeb

Validation batches of the vaccine against equine strangles Strangvac® is completed

3P Biopharmaceuticals, a leading CDMO specialized in the process development and GMP manufacturing of biologics has, together with the Swedish biotechnology company Intervacc AB and LIOF-Pharma ...