Regulatory/GMP Compliance

May 01, 2018
BioPharm International
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and systems.
May 01, 2018
BioPharm International
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
May 01, 2018
BioPharm International
Monetary benefits will outweigh the hassle of batch record harmonization, says Siegfried Schmitt, principal consultant at PAREXEL.
Apr 30, 2018
By BioPharm International Editors
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
Apr 30, 2018
By BioPharm International Editors
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
Apr 24, 2018
By BioPharm International Editors
EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.
Apr 20, 2018
By BioPharm International Editors
FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.
Apr 19, 2018
By BioPharm International Editors
The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.
Apr 16, 2018
By BioPharm International Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 11, 2018
By BioPharm International 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.
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