Standards/Regulations

Nov 07, 2017
By Pharmaceutical Technology Editors
While most pharma companies are in partial production using generators, few are operating at 100% capacity.
Nov 06, 2017
By Pharmaceutical Technology Editors
The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
Nov 06, 2017
By Pharmaceutical Technology Editors
The voluntary recall is due to blister packages containing the incorrect product.
Nov 03, 2017
By Pharmaceutical Technology Editors
The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.
Nov 02, 2017
Pharmaceutical Technology
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree.
Nov 02, 2017
Pharmaceutical Technology
FDA seeks to focus on problematic facilities and inform firms quickly about site problems.
Nov 02, 2017
Pharmaceutical Technology
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
Nov 02, 2017
Pharmaceutical Technology
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Oct 25, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.
Oct 24, 2017
By Pharmaceutical Technology Editors
The agency has published educational material for physicians promoting the benefits of biosimilars.
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