Regulatory/GMP Compliance

Aug 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Meticulous system configuration can prevent machines from taking over.
Aug 02, 2012
Pharmaceutical Technology
IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
Aug 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors compare direct combustion with rinse and swab sampling methods.
Aug 01, 2012
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.
Jul 09, 2012
ePT--the Electronic Newsletter of Pharmaceutical Technology
ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
Jul 03, 2012
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.
Jul 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Careful attention to detail will help to prevent valuable assets from "melting" away.
Jul 02, 2012
Pharmaceutical Technology
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
Jun 06, 2012
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.
Jun 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Even the slightest of errors in exponential calculations can cause the biggest of headaches.
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