Standards & Regulations

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.
Oct 23, 2017
By Pharmaceutical Technology Editors
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
Oct 20, 2017
By Pharmaceutical Technology Editors
The European Commission and EMA have created an action plan to address challenges identified by stakeholders involved in developing advanced therapies.
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