Standards/Regulations

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.
Oct 11, 2017
By Pharmaceutical Technology Editors
FDA published guidance on the format and content of REMS documents.
Oct 11, 2017
By Pharmaceutical Technology Editors
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
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