Regulatory/GMP Compliance

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
Nov 28, 2016
By BioPharm International Editors
Wockhardt Limited received a warning letter from FDA for CGMP violations.
Nov 18, 2016
By BioPharm International Editors
CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.
Nov 17, 2016
By BioPharm International Editors
At ICH’s November 2016 meeting, the council announced new members and new guidelines.
Nov 17, 2016
By BioPharm International Editors
The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
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