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Various other updates

Various other updates. Presented by: Karen S Ginsbury March 2012. FDA Process Validation Guidance. Finalized January 2011

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Various other updates

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  1. Various other updates Presented by: Karen S Ginsbury March 2012

  2. FDA Process Validation Guidance • Finalized January 2011 • Companies manufacturing for US market should have implemented it by now – would at the very least be expected to have a policy in place for legacy products and to follow the guide for new products being launched

  3. FDA Guidance on Contract Manufacturing • Promised in 2011 – not yet ready • Top of list – confirmed at PDA / FDA in September • Anticipated first half of 2012 • Will talk about sponsor responsibility for oversight of outsourced operations

  4. MHRA Compliance Program Status

  5. BIMPs Quality Documentation Draft

  6. BIMPs Quality Documentation Draft • Requirements are quite draconian • E.g. Need comparability from phase 1 – phase 2

  7. BIMP Quality DocumentationRequirements prior to phase 1!!!

  8. Are the requirements realistic • Will patients be denied new therapies because companies cannot invest the resources at this stage of development • What about risk to benefit for a critically ill patient • Where are you industry representatives and why haven’t you commented!!!

  9. Thank You for your attention Questions? Where to now?

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