Quality Systems Approach Overview
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Quality Systems Approach Overview Design Controls Design Controls Material Material Controls Controls Records, Records, Documents, & Documents, & Change Controls Change Controls Equipment & Equipment & Facility Controls Facility Controls Production & Production & Process Controls Process Controls Corrective & Corrective & Preventive Preventive Actions Actions Management Management
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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.
Transcript of Quality Systems Approach Overview
Quality Systems Approach Overview
Design ControlsDesign Controls
MaterialMaterialControlsControls Records,Records,
Documents, & Documents, &Change ControlsChange Controls
Equipment & Equipment & Facility ControlsFacility Controls
Production & Production & Process ControlsProcess Controls
Corrective &Corrective &PreventivePreventive
ActionsActions
ManagementManagement
Quality SystemAlignment and
Integration
Design Execute Monitor/Control
Design – determine what is really importantExecute – translate into service and manufacturingMonitor/Control – translate into quality assurance
Continuous Improvement
Example: Pharmaceutical
Capability and Control CycleDevelopment History
Technical Evaluations process and product Quality (GMP) Evaluations quality systems
Integrated Validation Master Planprocess product systems
Change Control process and product Change Control quality systems
Process Flow Document
Technology Transfer
Qualification
Validation process and product
Execute, Monitor and Control
Quality Management System
Begin with the End in Mind1. Compliant2. Capable3. Robust4. In Control5. Continuously Improving
Establish shared standards and expectations
Execute and monitor with best business practices.
Assess results against the standards and practices.
Document with FDA in Mind1. Clear2. Concise3. Correct4. Complete5. Confident
Balanced Scorecard
Behavior Needed
Dominance
Influence
Conscientiousness
Steadiness
Selection
Situation
People
Result
Action
Consequence
Scenario
Worst Case
Most Likely Case
Best Case
Decision
Plan
Approach
Deployment
Result
Responsibility of Highest Level of Management
Establish Quality Policy
Ensure that it is followed
Delegation by Management with Executive Responsibility
Establishment of quality objectives
Translation of objectives into methods and procedures
Implementation of quality system
How does Management Assure an Effective Quality System?
CAPA
Audits ManagementReview
How to Demonstrate Compliance
Procedures ...
Verbal Communications
Written records and documents
Establish [21 CFR 820.3(k)]
Define
Document
Implement
Key Elements of a Quality Manual
1. 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
Key Elements of a Quality Manual
10. Training programs and records for all employees11. In-coming inspection program for raw materials12. In-process analytical checks during processing13. Inventory control
14. Validation of equipment/systems/processes15. Cleaning validation16. Analytical methods validation17. Computer/controller validation18. Validation change control19. Revalidation program
Key Elements of a Quality Manual20. Audit programs - internally and externally21. Qualification of vendors22. Quality Control testing (in-process and finished
product testing)23. Complaint handling program24. Annual product reviews25. Stability Program26. Sample retention program27. Documentation control/storage28. Labeling and label control29. Specification development30. Generation and validation of analytical methods
Writing and ManagingStandard Operating Procedures
Controls
Approvals
Formatting
Readability
Change History
Cross References
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, ….)
Document Management
Structure
Segregation Documents in Review
Documents in Approval
Effective Documents
Archived Documents
Control
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
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
Managing Regulatory Training Compliance 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
How does Management Assure an Effective Quality System?
CAPA
Audits ManagementReview
A B C D E F G H I J K
Job Title/Employee Quality System 21 CFR Part 211 Subparts
(Your Organization’s Name)
Regulatory Responsibilities
Design ControlsDesign Controls
MaterialMaterialControlsControls Records,Records,
Documents, & Documents, &Change ControlsChange Controls
Equipment & Equipment & Facility ControlsFacility Controls
Production & Production & Process ControlsProcess Controls
Corrective &Corrective &PreventivePreventive
ActionsActions
Management
Controls
(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?
QUESTIONS
