Gestión De Riesgo En La Industria Farmacéutica

Content
ICH Q9 QUALITY RISK MANAGEMENT

Quality Risk Management ICH Q9
Albinus D’Sa, Ph.D. Office of Compliance, CDER, FDA October 2, 2006
Disclaimer: This presentation includes the authors views on quality risk management theory and practice. The presentation does not represent official guidance or policy of authorities or industry.
prepared by some members of the ICH Q9 EWG for exampleonly; not an official policy/guidance July 2006, slide 1

Content
ICH Q9 QUALITY RISK MANAGEMENT

Table of contents
1. Introduction 2. Scope 3. Principles of Quality Risk Management 4. General Quality Risk Management Process 5. Risk Management Methodology Annex I: Risk Management Methods and Tools 6. Integration of QRM process into Industry and Regulatory operations Annex II: PotentialApplications for QRM 7. Definitions 8. References
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2

Content
ICH Q9 QUALITY RISK MANAGEMENT

1. Introduction
Risk Management Quality Risk Management Quality Systems Harm Severity Stakeholder Product Life Cycle GMP Compliance

prepared by some members of the ICH Q9 EWG for example only;not an official policy/guidance

July 2006, slide 3

Content
ICH Q9 QUALITY RISK MANAGEMENT

2. Scope This guidance provides principles & examples of tools of quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycleof drug substances, drug (medicinal) products, biological and biotechnological products
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4

Content
ICH Q9 QUALITY RISK MANAGEMENT CONSIDERATIONS

2. Scope
• Drug substances, • Drug (medicinal) products, • Biological and biotechnological products Including the selection anduse of > Raw materials > Solvents > Excipients > Packaging and labelling materials > Components
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5

Content
ICH Q9 QUALITY RISK MANAGEMENT

3. Principles of Quality Risk Management
Two primary principles:

The evaluation of the risk to quality should be based on scientificknowledge and ultimately link to the protection of the patient

The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk

ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 6

Content
ICH Q9 QUALITY RISK MANAGEMENT

4. General Quality Risk ManagementProcess

Systematic processes designed to coordinate, facilitate and improve science-based decision making with respect to risk to quality

ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 7

Content
ICH Q9 QUALITY RISK MANAGEMENT

4. A General Quality Risk Management Process
Risk Communication

Initiate Quality RiskManagement Process Risk Assessment Risk Identification

Risk Analysis

Risk Evaluation
unacceptable

Risk Management tools

Risk Control Risk Reduction

Risk Acceptance

Team approach

Output / Result of the Quality Risk Management Process Risk Review Review Events

ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide8

Content
ICH Q9 QUALITY RISK MANAGEMENT CONSIDERATIONS

4. General Quality Risk Management Process
Team approach • Usually, but not always, undertaken by interdisciplinary teams from areas appropriate to the risk being considered e.g.
> > > > > > > > > Quality unit Development Engineering / Statistics Regulatory affairs Production operations Business, Sales and Marketing Legal Medical...