Sep 01, 2015
BioPharm International
China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.
Aug 24, 2015
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
Aug 21, 2015
The rapid microbiological growth-based method represents an alternative for the quantification of contaminants in filterable products.
Aug 18, 2015
Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
Aug 17, 2015
Challenges related to the reporting of out-of-specification results loom for contract testing laboratories.
Aug 01, 2015
BioPharm International
This article discusses cleaning validation of equipment dedicated to the production of a single API.
Jul 29, 2015
The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.
Jul 28, 2015
By BioPharm International Editors
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
Jul 13, 2015
By BioPharm International Editors
The International Conference on Harmonization has moved ICH M7(R1) Addendum to Step 3 of the ICH process.
Jul 06, 2015
Pharmaceutical Technology
Joe Kubicek, president and general manager of the Ansell Single Use Global Business Unit, discuss changes in how today’s pharmaceutical manufacturing and drug development companies approach their workers’ PPE and safety needs.