Regulatory/GMP Compliance

Feb 28, 2017
By BioPharm International Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Feb 15, 2017
By BioPharm International Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Feb 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.
Jan 25, 2017
By BioPharm International Editors
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
Jan 20, 2017
By BioPharm International Editors
FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.
Dec 20, 2016
By BioPharm International Editors
The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
Dec 01, 2016
BioPharm International
A consistent approach in assessing risk is an important aspect of successful quality management.
Dec 01, 2016
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on a limited budget.
Dec 01, 2016
BioPharm International
Biopharma must see regulators as partners in their efforts to provide safe and effective therapies.
Nov 28, 2016
By BioPharm International Editors
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
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