Quality Systems

May 16, 2017
By Pharmaceutical Technology Editors
The agency released several new and revised guidance documents regarding product-specific generic drug development.
May 16, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.
May 16, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.
May 15, 2017
Pharmaceutical Technology
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
May 15, 2017
Pharmaceutical Technology
The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
May 15, 2017
Pharmaceutical Technology
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
May 15, 2017
Pharmaceutical Technology
Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
May 11, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.
May 10, 2017
Equipment and Processing Report
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.
May 09, 2017
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
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