IPQ Newsletter » The News in Depth http://www.ipqpubs.com Subscribe now Sun, 05 Feb 2012 02:18:07 +0000 http://wordpress.org/?v=2.9.1 en hourly 1 Ranbaxy Consent Decree Fires FDA Warning Shot for Ex-US Pharma on Data Integrity http://www.ipqpubs.com/news/ranbaxy-consent-decree-provides-fda-warning-shot-for-ex-us-pharma-on-data-integrity/ http://www.ipqpubs.com/news/ranbaxy-consent-decree-provides-fda-warning-shot-for-ex-us-pharma-on-data-integrity/#comments Mon, 30 Jan 2012 21:00:20 +0000 Jerry http://www.ipqpubs.com/?p=5913 USP and IPEC-Europe Weigh in on GDPs for Excipients http://www.ipqpubs.com/news/usp-and-ipec-europe-weigh-in-on-gdps-for-excipients/ http://www.ipqpubs.com/news/usp-and-ipec-europe-weigh-in-on-gdps-for-excipients/#comments Thu, 19 Jan 2012 02:01:46 +0000 Jerry http://www.ipqpubs.com/?p=5860 IPQ’s Monthly Update for January is Now Available http://www.ipqpubs.com/news/ipqs-monthly-update-for-january-is-now-available/ http://www.ipqpubs.com/news/ipqs-monthly-update-for-january-is-now-available/#comments Wed, 18 Jan 2012 04:23:53 +0000 Jerry http://www.ipqpubs.com/?p=5885 FDA Generic Drugs Office Advances QbD, Review Processes and Quality Management System in Anticipation of User Fees http://www.ipqpubs.com/news/fda-generic-drugs-office-advances-qbd-review-processes-and-quality-management-system-in-anticipation-of-user-fees/ http://www.ipqpubs.com/news/fda-generic-drugs-office-advances-qbd-review-processes-and-quality-management-system-in-anticipation-of-user-fees/#comments Sat, 14 Jan 2012 21:56:44 +0000 Jerry http://www.ipqpubs.com/?p=5853 Consumer Complaints, FDA Inspection at Novartis Nebraska Plant Leads to Recalls and Temporary Manufacturing Shutdown http://www.ipqpubs.com/news/consumer-complaints-fda-inspection-at-novartis-nebraska-plant-leads-to-recalls-and-temporary-manufacturing-shutdown/ http://www.ipqpubs.com/news/consumer-complaints-fda-inspection-at-novartis-nebraska-plant-leads-to-recalls-and-temporary-manufacturing-shutdown/#comments Sat, 14 Jan 2012 19:39:47 +0000 Jerry http://www.ipqpubs.com/?p=5840 Key Pillars of a Quality Culture are Management Commitment, Sharing Inspection Results and Early QbD, Industry Execs Affirm http://www.ipqpubs.com/news/a-quality-culture-is-built-on-management-commitment-sharing-inspection-results-and-early-qbd-industry-execs-affirm/ http://www.ipqpubs.com/news/a-quality-culture-is-built-on-management-commitment-sharing-inspection-results-and-early-qbd-industry-execs-affirm/#comments Thu, 12 Jan 2012 05:14:27 +0000 Jerry http://www.ipqpubs.com/?p=5827 Not Keeping Current with Changing FDA Requirements and Slow Responses are Causing ANDA Approval Delays http://www.ipqpubs.com/news/not-keeping-current-with-changing-fda-requirements-and-slow-responses-are-causing-anda-approval-delays/ http://www.ipqpubs.com/news/not-keeping-current-with-changing-fda-requirements-and-slow-responses-are-causing-anda-approval-delays/#comments Sat, 07 Jan 2012 22:14:15 +0000 Jerry http://www.ipqpubs.com/?p=5809 ICH “Points to Consider” Part Two on Implementing Q8-10 Addresses Models, Design Space and Process Validation http://www.ipqpubs.com/news/ich-%e2%80%9cpoints-to-consider%e2%80%9d-part-2-on-implementing-q8-10-addresses-models-design-space-and-process-validation/ http://www.ipqpubs.com/news/ich-%e2%80%9cpoints-to-consider%e2%80%9d-part-2-on-implementing-q8-10-addresses-models-design-space-and-process-validation/#comments Wed, 04 Jan 2012 04:50:00 +0000 Jerry http://www.ipqpubs.com/?p=5774 FDA and EMA Formalize Mutual Inspection Reliance Program http://www.ipqpubs.com/news/fda-and-ema-announce-inspection-data-sharing-program/ http://www.ipqpubs.com/news/fda-and-ema-announce-inspection-data-sharing-program/#comments Wed, 04 Jan 2012 03:09:17 +0000 Jerry http://www.ipqpubs.com/?p=5766 Generic Drug Manufacturing Issues Draw FDA Warning Letters at Sandoz and Mylan http://www.ipqpubs.com/news/generic-drug-manufacturing-issues-draw-fda-warning-letters-at-sandoz-and-mylan/ http://www.ipqpubs.com/news/generic-drug-manufacturing-issues-draw-fda-warning-letters-at-sandoz-and-mylan/#comments Tue, 03 Jan 2012 04:39:12 +0000 Jerry http://www.ipqpubs.com/?p=5751