Tuesday, May 21, 2013
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2010-02-24 EU GMP PART III Explanatory notes for pharma manufacturers on the preparation of a Site Master File and content of a Site Master File2/24/201047.38 KBDownload
2010-02-24 Rx-360 Summary of EU GMPs: Explanatory Note on Preparation of Site Master Files2/24/201074.32 KBDownload
2010-02-16 Rx-360 Monitoring and Reporting Group Summary of Changes to Anti-Counterfeiting Directive2/24/201040.01 KBDownload
2010-02-16 Council Counterfeiting Document 2018-12-092/24/2010293.78 KBDownload
2009-08-09 Rx-360 Summary of FDA Guidance Documnet2/14/201037.47 KBDownload
2010-02-02 Rx-360 Summary of FDA Guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drugs2/1/201056.31 KBDownload
2010-02-02 FDA Guidancefor Industry, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products2/1/2010152.40 KBDownload
Q and A Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination1/27/201090.00 KBDownload
2010-01-20 Rx-360 Summary of Proposed Revisions to EU Part 1 Ch 2 Personnel1/20/2010123.09 KBDownload
2010-01-20 Proposed Revisions to EU Part 1 Ch 2 Personnel1/20/201056.79 KBDownload
2010-01-20 Rx-360 Summary of Proposed Revisions to EU Part 1 Ch 1 Quality Management System1/20/2010144.48 KBDownload
2010-01-20 Proposed Revisions to EU Part 1 Ch 1 Quality Management System1/20/201089.08 KBDownload
2009-12-29 Rx-360 Summary of FDA Final Guidance on Residual Solvents12/29/200965.05 KBDownload
2009-12-29 FDA Final Guidance on Residual Solvents12/29/200951.82 KBDownload
2009-12-14 CDC Editorial on Diethylene Glycol12/11/2009273.81 KBDownload
2009-08-20 Impact of Swine Flu on The Pharmaceutical Industry9/3/20093.05 MBDownload
2008-08-24 Summary of Health Canada's Guidance on Temperature Control8/24/200934.47 KBDownload
2008-08-24 Health Canada Guidelines for Temperature Control of Drug Products During Storage and Transportation GUI-00698/24/2009107.26 KBDownload
2009-08-09 Summary FDA Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination8/9/200937.47 KBDownload
2009-08-07 Anayltical Methods for Melamine Detection in Raw Materials8/9/200947.50 KBDownload
2009-08-06 FDA Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination8/9/2009136.64 KBDownload
Sumary Preentation US FDA Draft Generic API Impurities Guidance8/3/2009126.00 KBDownload
Summary Presentation: European Commission Report: Statistics of interceptions concerning articles suspected of infringing intellectual property8/3/20091.73 MBDownload
European Commission Report: Statistics of interceptions concerning articles suspected of infringing intellectual property rights8/3/2009980.38 KBDownload
Summary of US FDA Draft Guidance: Inclusion of PCIDs into Solid Oral Dosage Form Drug Products for Anticounterfeiting7/21/200939.73 KBDownload
US FDA Draft Guidance: Inclusion of Physical – Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anticounterfeiting7/21/2009UnknownDownload
US Senate Drug Device Accountability Act of 20095/5/2009295.23 KBDownload
US Senate Drug Device Accountability Act of 2009 Analysis5/5/200947.47 KBDownload
US Congress Food and Drug Adminsitration Gloablization Act of 2009 Analysis5/5/200986.44 KBDownload
US Congress Food and Drug Adminsitration Globalization Act of 20095/4/2009264.65 KBDownload
GHTF Final Guidance on Supplier Management4/7/2009715.07 KBDownload
Consortium Proposal - PowerPoint Presentation3/4/2009720.53 KBDownload
US Department of Justice Antitrust Letter2/20/2009194.87 KBDownload
  

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