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GXP Winter 2010: IVT Awards<\/b><\/a>
The Institute of Validation Technology held its annual Validation Week conference in Philadelphia, PA in October 2009. Awards were presented to the winners of the Journal of GXP Compliance “Article of the Year” as well as the “Kenneth G. Chapman” award for outstanding achievement in the field of validation.
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FDA Guidance on Pharmaceutical Quality Management System<\/b><\/a>
FDA has published an International Conference on Harmonization (ICH) guidance entitled Q10 Pharmaceutical Quality System.  The new FDA guidance describes a model to follow in designing an effective pharmaceutical quality management system and complements other ICH quality guidances that FDA has published including ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. Because it is based on current good manufacturing practice (CGMP) and International Organization for Standardization (ISO) concepts, FDA believes that this guidance is not only intended for new applications, but can be implemented at any time throughout the lifecycle of a product and is not intended to create any new expectations beyond current regulatory requirements.  FDA has already indicated that it expects industry to understand all aspects of their product to ensure the quality of products and that industry will increase the number of their supplier audits to ensure the integrity of the supply chain starting with raw materials.
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Two Jailed for Ignoring Sterility Standards<\/b><\/a>
I am not sure how many people outside of North Carolina saw the news last week of the plea bargain that sent two men, Aniruddha Patel and Ravindra Kumar Sharma, to jail.  They were the plant manager and the quality control director, respectively, of a plant in Angier, NC owned by the company AM2 PAT.  The two men were sentenced in Raleigh, NC to four and a half years in jail on February 23, 2009 for fraud and allowing tainted drugs into the marketplace.  The two got a reduced sentence by agreeing to aid the prosecution of the CEO of the company, Dushyant Patel, who is still at large
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FDA Draft Guidance: Good Importer Practice<\/b><\/a>
In January 2009, the US Food and Drug Administration published the Guidance for Industry, Good Importer Practices, Draft Guidance. Comments are accepted until April 12, 2009.
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Genetically Engineered Animals: The Future of Biopharmaceutical Production<\/b><\/a>
On February 6, 2009, the US Food and Drug Administration approved the first therapeutic made from genetically engineered animals (http:\/\/www.fda.gov\/bbs\/topics\/NEWS\/2009\/NEW01952.html). (Note: This comes more than two years after the approval in the European Union on 08\/02\/06.) ATryn® is a recombinant form of human antithrombin and is isolated from the milk of goats that have been genetically engineered to produce the protein.
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Post your questions to industry experts in the GXP Talk section of our Forum!<\/b><\/a>
Have a compliance question? Post it in the GXP Talk section of the Forum.
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