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FDA Process Validation and Compliance Updates for Pharmaceutical Industry

Stay informed with the latest FDA guidance on process validation, contract manufacturing, and compliance programs for pharmaceutical companies. Get insights from industry expert Karen S. Ginsbury. Learn about the impact on legacy and new products. Are the upcoming BIMPs quality documentation requirements realistic? Address patient access to new therapies. Time to act!

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FDA Process Validation and Compliance Updates for Pharmaceutical Industry

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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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