Regulatory/GMP Compliance

Aug 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
Aug 27, 2018
By Pharmaceutical Technology Editors
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding.
Aug 24, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
Aug 23, 2018
By Pharmaceutical Technology Editors
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
Aug 23, 2018
By Pharmaceutical Technology Editors
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
Aug 16, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Aug 15, 2018
By Pharmaceutical Technology Editors
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
Aug 13, 2018
By Pharmaceutical Technology Editors
Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine (Thyroid Tablets, USP) after FDA issues import alert affecting the active ingredient.
Aug 10, 2018
By Pharmaceutical Technology Editors
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
Aug 10, 2018
By Pharmaceutical Technology Editors
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
native1_300x100
lorem ipsum