Quality Systems

Jun 01, 2017
BioPharm International
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
Jun 01, 2017
BioPharm International
Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
May 22, 2017
By BioPharm International Editors
The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.
May 15, 2017
BioPharm International
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
May 15, 2017
BioPharm International
Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.
May 09, 2017
By BioPharm International Editors
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
Apr 25, 2017
By BioPharm International Editors
Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.
Apr 19, 2017
The number of deficiencies found in foreign and UK-based facilities increased in 2016.
Apr 13, 2017
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
Apr 12, 2017
By BioPharm International Editors
The agency cited the company’s India facility for batch failures and data integrity problems.
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