GMPs

Sep 03, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.
Sep 03, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.
Sep 02, 2009
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Thanks to their keen observations, these auditors reveal the true culprits of deviations.
Sep 01, 2009
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
When validating automated systems from third-party providers, using the V model and failure modes effects and criticality analysis (FMECA) early in the process can help.
Sep 01, 2009
Pharmaceutical Technology
The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances.
Aug 19, 2009
Equipment and Processing Report
By Pharmaceutical Technology Editors
The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.
Aug 13, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.
Aug 02, 2009
Pharmaceutical Technology
By Pharmaceutical Technology Editors
An ounce of contamination usually leads to a mountain of investigation.
Jul 23, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.
Jul 16, 2009
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.
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