Regulatory/GMP Compliance

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.
Apr 03, 2018
By Pharmaceutical Technology Editors
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
Apr 03, 2018
Designing a mechanical integrity program using existing best practices can help pharmaceutical manufacturers comply with OSHA’s standard for process safety management.
Apr 02, 2018
Pharmaceutical Technology
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
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