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