Quality Systems

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 09, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
May 09, 2017
By Pharmaceutical Technology Editors
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
May 08, 2017
Pharmaceutical Technology
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
May 08, 2017
Pharmaceutical Technology
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
May 02, 2017
Pharmaceutical Technology
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
May 02, 2017
Pharmaceutical Technology
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
May 02, 2017
Pharmaceutical Technology
Value-based medicine is putting patients at the center of pharmaceutical R&D and forcing the industry to move from treatment to prevention.
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