Regulatory/GMP Compliance

Feb 12, 2018
By BioPharm International Editors
FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.
Feb 07, 2018
By BioPharm International Editors
The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
Feb 01, 2018
BioPharm International
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
Feb 01, 2018
BioPharm International
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
Feb 01, 2018
BioPharm International
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Feb 01, 2018
BioPharm International
As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
Feb 01, 2018
BioPharm International
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
Feb 01, 2018
BioPharm International
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
Feb 01, 2018
By BioPharm International Editors
Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
Jan 31, 2018
FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.
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