How pharmacy and bio tech companies benefit from fda

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How pharmacy and bio tech companies benefit from fda

  1. 1.  FDA report: Pharmaceutical Quality for the 21st Century: A Risk-Based Approach Recommends Quality-by-design for process validation Process Development, Process Analytical Technologies, and Corrective and Preventive Actions (CAPA)
  2. 2.  New guidelines will result in decreasing cross- contamination Concentrate on validation in Current Goods Manufacturing Processes (cGMP)
  3. 3.  Maintain rigorous quality and process controls Implement PAT (process analytical technologies) Tools: process controls, process analyzers, multivariate data acquisition and analysis
  4. 4.  Ensure public safety Expand your knowledge and expertise through industry consolidations and alliances
  5. 5.  Michael R. Goodman, compliance specialist, Compliance Insight Reducing cross-contamination is not difficult
  6. 6.  Improve using the quality-by-design validation process Review other pharmaceutical development ideas utilized throughout the industry Demand superior quality throughout the manufacturing life cycle Apply strict risk management processes throughout
  7. 7.  Initial process validation Design process validation Equipment evaluation Range assessment research study
  8. 8.  Appropriate range Significant steps Listing specifics required for successfully scaling up business
  9. 9.  How do daily and normal operations affect quality? What aspects impact equipment tolerance? What is the best system to connect equipment material, systems material and in-process material?
  10. 10.  Choose the right equipment Minimum three consecutive batches to validate Focus a product line on a single product Alternative: review the last cleaning agent used on a specific line and set strenuous health- based limits for carryover of production lines
  11. 11.  Trend towards increasing usage by pharmaceutical companies CMOs require careful and constant monitoring and regulating Set strict audit parameters
  12. 12.  Compliance Insight, Inc. Your Hands-On Quality and Regulatory Specialists Our services include GMP consulting, audit preparation, FDA mock inspections, FDA response assistance, vendor/contract audits, GMP training and accreditation, new construction compliance, regulatory consulting, investigations, biosafety and viral testing consulting; clinical trial audits and more. For more information visit http://compliance- insight1.com/

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