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Quality by design approach is a better process
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Quality by design approach is a better process

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The quality by design approach, first developed by Joseph M. Juran, is now being issued by the Food and Drug Administration to help revolutionize the industry of pharmaceuticals. In a report called …

The quality by design approach, first developed by Joseph M. Juran, is now being issued by the Food and Drug Administration to help revolutionize the industry of pharmaceuticals. In a report called 'Pharmaceutical Quality for the 21st Century: A Risk-Based Approach', the FDA emphasizes strict control and understanding along with quality over the development of drugs and their manufacturing processes. Discover the advantages of the new approach.

Published in Health & Medicine , Business
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  • 1. Quality by Design Approach is a Better Process Validation for Vaccines that are Biologically Derived
  • 2. Quality by Design• Quality by design approach ▫ Developed by Joseph M. Juran, now being issued by the Food and Drug Administration to help revolutionize the industry of pharmaceuticals• A report called Pharmaceutical Quality for the 21st Century: A Risk-Based Approach‘ ▫ FDA emphasizes strict control and understanding along with quality over the development of drugs and their manufacturing processes
  • 3. New Approach• Michael R. Goodman, compliance specialist at Compliance Insight, says ▫ New approach is more advantageous than standard methods that have routinely been used for process validation of pharmaceuticals• Advantages include ▫ Lowering potential risks ▫ Gaining more and understanding of processes ▫ Setting up in-process controls
  • 4. 21st Century• Until 1990, Goodman explains, pharmaceutical companies used the Quality after Design approach• Approach required introducing a process development fragmented approach ▫ Focused on process development by encouraging minimizing risk by predicting problems that could potentially arise from external and internal sources• Approach focused on the development of processes with regards to their validation
  • 5. New Approach• New approach allows planning the quality of pharmaceutical drugs along with their dosage forms• Traditional approach used process validation that emphasized after-process inspections and in-process ones as well
  • 6. Focus• New approach focuses on ▫ Machinery - Equipment is monitored on regular basis for proper calibration, targets being met for fill-control and maintenance ▫ Controls and checks -Use of automation and ensuring the best possible final product with critical measures ▫ Raw materials - Monitoring all aspects including all of the chemicals, ingredients and packaging used ▫ Manufacturing process - Every stage of the process contamination is checked and emphasis is placed on finding the best possible process for manufacturing ▫ Human handling of pharmaceuticals is discouraged while automated manufacturing is recommended
  • 7. Facts• 380,000 children that received this polio vaccine ▫ 51 children ended up becoming 100% paralyzed following a dose• 40,000 children went on to develop polio symptoms ▫ 113 other people ended up paralyzed, of which five of them died• Five children died after a dose• Health agency of the government determined that 120,000 doses in the production pools contained a live virus
  • 8. Cutter Laboratories• Cutter laboratories used inconsistent glass and did not take into consideration the viral curve of reduction over time• Evidence pointed to the fact that 11 batches were not manufactured consecutively• Using new approach this could have all been avoided
  • 9. Consequences• Using new Quality by Design approach the vaccine would not have had the same consequences• Approach includes Corrective and Preventive Actions, Process Development and Process Analytical Technologies
  • 10. Compliance Experts• 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/