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September 01, 2009
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.
August 19, 2009
The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help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.
August 13, 2009
The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.
August 02, 2009
An ounce of contamination usually leads to a mountain of investigation.
July 23, 2009
The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.
July 16, 2009
The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.
July 02, 2009
Some GMP agents seem to find a way to squander time, money, and common sense.
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.
June 17, 2009
To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.
June 11, 2009