Information about pharmaceutical manufacturing compliance and validation issues.
September 12, 2006
By:Jill Wechsler
ePT--the Electronic Newsletter of Pharmaceutical Technology
Washington, DC (Sept. 12)—The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here
 |
September 7, 2006
By:Douglas McCormick
ePT--the Electronic Newsletter of Pharmaceutical Technology
Washington, DC (Sept. 1) — In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.
|
September 2, 2006
By:David Fortunato
Pharmaceutical Technology
As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.
|
March 8, 2007
By:Maribel Rios
ePT--the Electronic Newsletter of Pharmaceutical Technology
Rockville, MD (Mar. 1)-Sending Warning Letters to 8 manufacturers and 12 distributors, The US Food and Drug Administration ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate.
|
March 1, 2007
By:Brianne Harrison
ePT--the Electronic Newsletter of Pharmaceutical Technology
Rockville, MD (Feb. 1)-The US Food and Drug Administration issued a revised warning letter to Actavis Totowa, LLC, citing ?significant deviations from the current Good Manufacturing Practice regulations.?
|
March 1, 2007
By:Erik Greb
ePT--the Electronic Newsletter of Pharmaceutical Technology
Rockville, MD (Jan. 5)-The US Food and Drug Administration issued a Warning Letter to Bell-More Laboratories following the agency?s August 2006 inspection of the company?s Hampstead pharmaceutical facility.
|
January 2, 2007
By:Richard J. Forsyth, Alain Leblanc, Mark Voaden
Pharmaceutical Technology
An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.
|
| 
Quality Contract Manufacuturing for semi-solids and liquids
Achieve optimum FTIR performance, sensitivity, reliability and value with Shimadzu spectrometers.
Introducing the ACQUITY UPLC H-Class System, the new UPLC system for HPLC users
Celebrating 35 years of processing solutions! Join us, May 4-6, in Rosemont, IL.
Introducing the ACQUITY UPLC H-Class System, the new UPLC system for HPLC users
Buy new and used pharmaceutical equipment, used process equipment and laboratory equipment at LabX. Auctions, classifieds, and post FREE wanted ads to locate equipment.
Try a complimentary sample of the new ultra-pure gasket from Gore PharmBIO Products
Major Biotech & Pharmaceutical Equipment Auction from Pfizer, Merck & More
Special offers on new and improved products from Restek.
See the latest news from Optima Group pharma.