Regulatory/GMP Compliance

Oct 02, 2016
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
Sep 23, 2016
By BioPharm International Editors
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
Sep 01, 2016
By BioPharm International Editors
FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
Sep 01, 2016
BioPharm International
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
Aug 17, 2016
By BioPharm International Editors
The Chinese facility was cited for data integrity violations.
Aug 15, 2016
By BioPharm International Editors
The agency has adopted guidelines on the pharmacovigilance of biological drugs.
Aug 10, 2016
By BioPharm International Editors
FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.
Aug 03, 2016
By BioPharm International Editors
Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.
Aug 01, 2016
BioPharm International
Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.
Jul 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
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