Regulatory/GMP Compliance

Oct 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The material of construction is a factor in the recovery of residue in cleaning validation. An analysis of existing recovery data showed that recovery factors for drug products on various materials of construction may be categorized into several groupings.
Oct 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.
Sep 13, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.
Sep 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Poor processing and misguided projections lead to trashed product.
Sep 01, 2007
Pharmaceutical Technology Europe
The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.
Sep 01, 2007
Pharmaceutical Technology Europe
The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.
Aug 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Production sometimes follows the law of supply and reprimand.
Jul 12, 2007
ePT--the Electronic Newsletter of Pharmaceutical Technology
A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.
Jul 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The good ol' days weren't always good.
Jul 02, 2007
Pharmaceutical Technology
By Pharmaceutical Technology Editors
This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.
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