Quality Assurance/Quality Control

Noteworthy Historical Cases of Adverse Drug Reactions

March 02, 2020

A brief overview of three notable cases of adverse drug reactions.

Playing Catch Up with Big Data in Europe

March 02, 2020

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.

The Benefits of Outsourcing Stability Testing

March 02, 2020

Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.

WuXi Biologics Provides Update on Operations in Light of Coronavirus Outbreak

February 14, 2020

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

FDA’s Office of Pharmaceutical Quality Publishes Annual Report

February 12, 2020

The report details OPQ’s accomplishments over the past five years.

Global Supply Issues Create Challenges

February 02, 2020

Increased reliance on foreign producers raises concerns and spurs collaborations.

Data Management Practices

February 02, 2020

Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.

How Advanced Mass Spectrometry Technologies and Workflows are Delivering Comprehensive Protein Characterization

February 02, 2020

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

MilliporeSigma’s New Microbial Bioburden Testing System Offers Enhanced Results and Increased Productivity

January 31, 2020

Pharmaceutical Technology's In the Lab eNewsletter

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

Quality Oversight Failures Found at New Jersey Facility

January 17, 2020

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.