Quality Systems

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.
Apr 01, 2017
BioPharm International
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
Apr 01, 2017
BioPharm International
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
Apr 01, 2017
BioPharm International
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
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