GMPs

Dec 02, 2017
Pharmaceutical Technology
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
Nov 27, 2017
By Pharmaceutical Technology Editors
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
Nov 06, 2017
By Pharmaceutical Technology Editors
The agency published guidance regarding OTC aspirin products that have cardiovascular-related images in their labels.
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
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Nov 02, 2017
Pharmaceutical Technology
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
Oct 31, 2017
By Pharmaceutical Technology Editors
A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.
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 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 11, 2017
By Pharmaceutical Technology Editors
FDA published guidance on the format and content of REMS documents.
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