ICH Q10: Pragmatic Implementation

Since a few years, European, American, and Japanese regulatory Agencies communicate on Quality Management principles. ICH Q10 completes these communications and reinforces requirements regarding Quality Management System in Pharmaceutical area. The main issue not being only to know how what is a Quality Management System but above all to know how to implement it without completely turning upside down the existing system and while keeping compliance with Good Manufacturing Practices. Others texts and standards can also help to put your organization into conformity in a pragmatic manner. You will have also to include Knowledge Management in your action plan if you want to succeed in continual improvement.

 Know the new requirements from ICH Q10 at the different steps of product life cycle.

 Know the mainstays of Pharmaceutical Quality System according to ICH Q10.

 Know how to integrate ICH Q10 requirements in the existing Quality System in an appropriate manner proportionate to the company and to the different steps of product life cycle.

 Know how to take into account and integrate requirements from others standards and European, American, and Japanese regulatory guidance’s relating to Quality Management System.

 Know how to define a process and implement process performance monitoring.

 Know how to use Knowledge Management and Quality Risk Management to define pertinent and efficient indicators.

 Understand the importance of employee awareness and communication on the Quality System to ensure product quality improvement and system efficacy.

1. ICH Q10 Objectives regarding cGMP

What ICH Q10 could bring to pharmaceutical industry? What are the differences between cGMP and ICH Q10? Benefits, History.

2. ICH Q10 Requirements

The new requirements a Pharmaceutical Quality System should be in compliance with all along product life cycle according to ICH Q10. The 4 pillars of Pharmaceutical Quality System: 1) Process Performance and Product Quality Monitoring System. 2) Corrective Action and Preventive Action (CAPA) System. 3) Change Management System. 4) Management Review of Process Performance and Product Quality.

3. Requirements of others Standards and Guidance’s

What are the others Standards and European, American, and Japanese regulatory guidance’s to take into account? What are the requirements of these Standards and regulatory guidance’s? What the standards that could provide pragmatic solutions?

4. Process Approach, PDCA Dynamic, and horizontal view « client – client » in Pharmaceutical Industry

What is a Process Approach? Notion of client in Pharmaceutical Industry. Where Quality Assurance stands in the Pharmaceutical Quality System? How ICH Q10 fits into cGMP?

5. Risk Analysis: Process and Product Quality Diagnostic Tool

Make decisions from practical and well thought out data. Preliminary step for implementing indicators and control over Process and Product.

6. Management and Communication

Management Responsibilities. Management Reviews. Responsibilities and Resources. The stakes of communication in the appropriation of Pharmaceutical Quality System.

7. Steps to obtain a Pharmaceutical Quality System coherent with ICH Q10, cGMP, and Company Objectives

Review existing system. Define implementation, objectives, resources, monitoring tools. The implementation, training / information, action plan. Implement pertinent and efficient indicators. Management, internal communication, review and continual improvement. Quality Manual. Quality Plans. Procedures.

8. Continual Improvement

Knowledge Management. Identify variation causes. Analyze indicator data to evaluate the control over the Pharmaceutical Quality System and put into place appropriate actions for continual improvement.

9. Synthesis
The key points to remember.

PRACTICAL CASE STUDIES

Several practical case studies are proposed all along the training session

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.