Regulatory/GMP Compliance

Sep 01, 2017
BioPharm International
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Aug 25, 2017
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
Aug 24, 2017
By BioPharm International Editors
The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.
Aug 23, 2017
By BioPharm International Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
Aug 23, 2017
By BioPharm International Editors
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
Aug 21, 2017
By BioPharm International Editors
The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.
Aug 18, 2017
By BioPharm International Editors
The agency published guidance on identifying trading partners under DSCSA.
Aug 14, 2017
By BioPharm International Editors
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
Aug 14, 2017
By BioPharm International Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Aug 10, 2017
By BioPharm International Editors
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
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