Quality Assurance/Quality Control

Feb 02, 2018
Pharmaceutical Technology
Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
Feb 02, 2018
By Pharmaceutical Technology Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
Feb 02, 2018
Pharmaceutical Technology
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
Feb 01, 2018
Pharmaceutical Technology
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
Jan 24, 2018
Viewpoint: The revised Annex 1 on sterile manufacturing includes incorrect and ambiguous statements that must be fixed before implementation.
Jan 19, 2018
By Pharmaceutical Technology Editors
Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.
Jan 17, 2018
By Pharmaceutical Technology Editors
The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.
Jan 05, 2018
Pharmaceutical Technology's In the Lab eNewsletter
In a roundtable Q&A with biopharma executives, the vulnerability and challenges of dealing with extractables and leachables in single-use bioreactor bags are explored.
Jan 04, 2018
By Pharmaceutical Technology Editors
The company is voluntarily recalling product because of glass particles found in vials.
Jan 02, 2018
Pharmaceutical Technology
A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.
native1_300x100
lorem ipsum