OR WAIT null SECS
December 12, 2018
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
December 05, 2018
Integration of two separate chromatography data systems boosts workflow efficiency.
December 02, 2018
A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.
Microbial identity data can be critical for determining contamination sources.
Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.
Simplified role-based training can lead to better quality metrics and compliance.
Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.
Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
November 29, 2018
A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.
The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.