Quality Systems Approach Overview

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An overview of the Quality Systems Approach used by the FDA presented as a tool for use in business and industry to design, lead, and manage quality.

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Quality Systems Approach Overview

  1. 1. Quality Systems Approach Overview Corrective & Preventive Actions Production &Design Controls Process Controls Management Material Equipment & Controls Facility Controls Records, Documents, & Change Controls
  2. 2. Quality SystemAlignment and Integration Continuous Improvement Design Execute Monitor/Control Design – determine what is really important Execute – translate into service and manufacturing Monitor/Control – translate into quality assurance
  3. 3. Example: Pharmaceutical
  4. 4. Capability and Control Cycle Development History Integrated Validation Master Plan process product systemsBegin with the End in Mind2. Compliant Establish shared standards3. Capable Process Flow Document and expectations4. Robust5. In Control6. Continuously Improving Technology Transfer Qualification Document with FDA in Mind 2. Clear Execute and monitor with 3. Concise Validation process and product best business practices. 4. Correct 5. Complete Execute, Monitor and Control 6. Confident Technical Evaluations process and product Quality (GMP) Evaluations quality systems Change Control process and product Change Control quality systems Assess results against the standards and practices. Quality Management System
  5. 5. Balanced Scorecard
  6. 6. Behavior NeededDominanceInfluenceConscientiousnessSteadinessSelection
  7. 7. SituationPeopleActionResultConsequence
  8. 8. ScenarioWorst CaseMost Likely CaseBest CaseDecision
  9. 9. PlanApproachDeploymentResult
  10. 10. Responsibility of Highest Levelof Management Establish Quality Policy Ensure that it is followed
  11. 11. Delegation by Managementwith Executive Responsibility Establishment of quality objectives Translation of objectives into methods and procedures Implementation of quality system
  12. 12. How does Management Assurean Effective Quality System? CAPA Management Audits Review
  13. 13. How to Demonstrate Compliance Procedures ... Verbal Communications Written records and documents
  14. 14. Establish [21 CFR 820.3(k)] Define Document Implement
  15. 15. Key Elements of a Quality Manual1. Generation and maintenance of master production batch records.2. Generation of routine batch records3. Generation and maintenance of Standard Operating Procedures4. Generation and maintenance of preventive maintenance procedures5. Generation and maintenance of calibration procedures6. Generation and maintenance of equipment logbooks7. Generation and maintenance of cleaning procedures8. Generation and maintenance of deviation/failure reports9. Generation of rework procedures
  16. 16. Key Elements of a Quality Manual 1. Training programs and records for all employees 2. In-coming inspection program for raw materials 3. In-process analytical checks during processing 4. Inventory control 6. Validation of equipment/systems/processes 7. Cleaning validation 8. Analytical methods validation 9. Computer/controller validation 10. Validation change control 11. Revalidation program
  17. 17. Key Elements of a Quality Manual1. Audit programs - internally and externally2. Qualification of vendors3. Quality Control testing (in-process and finished product testing)4. Complaint handling program5. Annual product reviews6. Stability Program7. Sample retention program8. Documentation control/storage9. Labeling and label control10. Specification development11. Generation and validation of analytical methods
  18. 18. Writing and ManagingStandard Operating Procedures Controls Approvals Formatting Readability Change History Cross References
  19. 19. Developing Batch Records CFR 211.188 Prepared for each batch of drug product produced Include complete information relating to production and control of each batch (signed, dated and checked accurate reproduction of master production or control record, documentation of accomplished significant steps in manufacture, processing, packing or holding – dates, equipment and lines, specific identification of components and in-process material, ….)
  20. 20. Document Management Structure Segregation  Documents in Review  Documents in Approval  Effective Documents  Archived Documents Control
  21. 21. Complaint Management CFR 211.198 Mechanism  Designated person in quality group  Logged with unique number  Sender  Detail  Sample  Appropriate storage conditions  Investigation methodology  Response  Reference book
  22. 22. Annual Product Review CFR 211.180 (e) FDA Requirement Annual Reports  Summary of all findings  Sent to FDA by product NDA anniversary date Review of batches  Deviations  Failures  Out of Specifications  Stability Profiles  Visual verification  Retained samples
  23. 23. Managing Regulatory TrainingCompliance CFR 211.25 Education, Training, and Experience Enable to perform assigned functions  Particular operations performed  Current Good Manufacturing Practice  Written procedures related to assigned functions Continuing basis Sufficient frequency Documented Follow-up
  24. 24. How does Management Assurean Effective Quality System? CAPA Management Audits Review
  25. 25. (Your Organization’s Name) Regulatory Responsibilities Job Title/Employee Quality System 21 CFR Part 211 Subparts    A B C D E F G H I J K                                                                                                                                                                                                                                                                                                                                                              
  26. 26. Management Production & Design Controls Process Controls Corrective & Preventive ActionsMaterial Equipment &Controls Facility Controls Records, Documents, & Change Controls Controls
  27. 27. (Your Organization’s Name)Regulatory Responsibilities• What are the responsibilities?• Where are the gaps?• What are the risks?• What are the consequences?• What are the opportunities?• What are the rewards?
  28. 28. QUESTIONS

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