Quality

Aug 24, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
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 03, 2015
By Pharmaceutical Technology Editors
FDA issues guidance regarding fees for drug compounding outsourcing facilities.
Aug 02, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
Aug 02, 2015
Pharmaceutical Technology
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.
Aug 02, 2015
Pharmaceutical Technology
Paperless operations improve efficiency and increase assurance of product quality.
Aug 01, 2015
Pharmaceutical Technology
China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.
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
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology 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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.