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 ...
JD Supra

The Medicines Company v. Hospira - Preparation of validation batches by a contract manufacturer for FDA submission creates an on-scale bar

On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA ...
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 ...