Quality Assurance/Quality Control

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.
Jan 02, 2018
Pharmaceutical Technology
Process validation is an extension of biologics development processes.
Jan 02, 2018
Pharmaceutical Technology
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
Jan 02, 2018
By Pharmaceutical Technology Editors
PharMEDium Services, LLC voluntarily recalled some lots of product because of a lack of sterility assurance.
Dec 28, 2017
By Pharmaceutical Technology Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
Dec 20, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
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