Quality

Jul 12, 2017
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company is voluntarily recalling Sten Z and M1 Alpha capsules because the product contains derivatives of anabolic steroids, which makes them unapproved drugs.
Jul 12, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
Jul 10, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
Jul 02, 2017
Pharmaceutical Technology
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Regulations and business changes have altered Big Pharma’s place in the industry.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.
Jul 02, 2017
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial.
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