Pre-Conference Workshop to the 6th European GMP Conference "How to establish Quality Metrics"
Speakers
Dick Bonner, Qualified Person and ECA Chairman
Karthik Iyer, FDA
Ian Jackson, BSc (Hons) MRSC MHRA, UK
Henny Koch, Qimp Management Systems
Dr Andreas König, Vice President Manufacturing & Quality Aenova-Group
Dr Bernd Renger, Qualified Person and Immediate Past Chairman EQPA
Objectives
This pre-conference session is designed to discuss the implementation of Quality Metrics in the manufacture of medicinal products and APIs. In the centre will be challenges and possible solutions to identify, measure and report meaningful Quality Metrics. For that purpose the ECA Foundation and its interest group, the European Qualified Person Association, have invited stakeholders from industry and authorities
Background
Quality can be measured on different levels. This can take place on the level of products or processes. It can also be used as a measure of the site`s ability to manufacture products fit for the intended use.
While so far only compliance and non-compliance were measured, Quality Metrics are a new step in the GMP development. Quality Metrics in itself are not new, though. They have already been used in pharmaceutical industry for years – even though mainly internally to measure and optimize the performance. However, currently there is no harmonised approach in place. This means that data can not be compared because of different standards.
The US FDA has set up an initiative to use Quality Metrics for risk based inspections. This development was triggered by the Food and Drug Administration Safety and Innovation Act. However, in Europe agencies also use Quality Metrics. Therefore, a harmonised approach possibly helps regulators worldwide to separate manufacturing sites with very poor standards from those continuously working on quality improvement.
In the end Quality Metrics enable companies with a high quality performance to benefit from a continuous investment in GMP.
Target Group
This Pre-Conference Session addresses Quality and Manufacturing Managers who are involved in the planning and improvement of quality processes.
Programme
FDA’s Quality Metrics Program
Overview about the current status
Quality Metrics to support drug quality and surveillance for CDER
Impact for pharmaceutical industry
Karthik Iyer, FDA
The EMA view on Quality Metrics
Quality Metrics - a European Perspective
Globalisation challenges
Key signs of quality culture
How can quality culture be assessed?
Esther Martinez, EMA, UK
Developing, Establishing and Monitoring of Meaningful Quality Metrics in Quality Control
Quality Metrics - Challenges and risks
Benchmarking based on different data sets
Good Quality Control Practices
Lean, Efficient and high Quality - does this fit?
Some meaning Quality Metrics for Lab activities
Dr Bernd Renger, Qualified Person and Immediate Past Chairman EQPA
How to use Quality Metrics to control the Supply Chain and the Supplier
How to oversight the Supply Chain?
Is a complex supply chain always a risk?
How to control and measure the supplier in the supply chain
Supply Chain and Supplier Metrics
Dick Bonner, Qualified Person and ECA Chairman
Inspections based on Compliance Information. The MHRA Risk-Based Inspection Programme
How to anticipate supply chain and compliance risks
How to improve compliance-related communication with industry
Implementation a risk-based escalation process regarding inspection results within MHRA
Ian Jackson, MHRA
Quality Metrics and Management Review
Quality Culture as the basis for quality improvements
How to involve the management in Quality Metrics
Set up of a practical review system
Follow up actions on management reviews
Henny Koch, Qimp Management Systems
Case Study: Quality Metrics at Aenova-Group
Industry Quality Metrics – typical data sets and reports
How to measure Quality Metrics in daily practice
Lessons learned from implementation
Comparison of quality metrics – potential risks and challenges
Dr Andreas König, Senior Vice President corporate Quality & HSE at Aenova-Group
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