Regulatory/GMP Compliance

Apr 20, 2018
By Pharmaceutical Technology Editors
A federal judge from the Eastern District of Arkansas entered into a consent decree with Cantrell Drug Company.
Apr 19, 2018
By Pharmaceutical Technology Editors
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Apr 16, 2018
By Pharmaceutical Technology Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 12, 2018
Equipment and Processing Report
The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.
Apr 11, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Apr 09, 2018
By Pharmaceutical Technology Editors
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
Apr 04, 2018
By Pharmaceutical Technology Editors
A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis.
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