Regulatory/GMP Compliance

Jul 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
My audit host clearly knew and lied about the planned changes.
Jun 29, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.
Jun 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
I always suspected that our purchasing manager had agreed to this just to save money . . .
Jun 02, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .
Jun 02, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Noting several violations in current good manufacturing practice regulations, the US Food and Drug Administration has issued a Warning Letter to Wyeth Pharmaceuticals?s (Collegville, PA) manufacturing facility in Puerto Rico.
May 25, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.
May 04, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Sigma-Aldrich Corporation (St. Louis, MO) has acquired Iropharm, Honeywell International's custom chemical synthesis business in Arklow, Ireland. Terms of the cash purchase were not disclosed.
May 04, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
In a May 2 Federal Register notice (1), the US Food and Drug Administration withdrew its Jan. 17 direct final rule, "Current Good Manufacturing Practice Regulation and Investigational New Drugs" (2), which would have exempted manufacturing of drugs for Phase I clinical trials from most provisions of 21 CFR 211.
May 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Animal testing and accounting can both be hazardous.
Apr 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Vitamin D and a sunny window shed som light on product stability.
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