FMEA-辉瑞企业培训资料.ppt

Managing Pharmaceutical Quality: Risk or Uncertainty Management?
Ajaz S. Hussain, .
Office of Pharmaceutical Science
CDER, FDA
PQRI Workshop February 1, 2005
1
What is Quality?
What is pharmaceutical quality?
consistent delivery of the label performance and lack of contamination.
operationalzed via a set of pre-specified quality attributes (., specifications, limits) and through the CGMP regulations.
FDA, in its quality definition, is standing in for the customer—and it is apparent that health care practitioners and patients highly value an additional drug attribute: product availability
Good pharmaceutical quality represents an acceptably low risk of failing to achieve the desired clinical attributes.
2
Management Goals
Improving quality and ensuring availability
Optimal use of our resources
A systems approach to CMC review and CGMP investigations
Based on knowledge and process understanding
Achieving “quality by design”
Demonstrating “science of design”
Continuous learning and improvement through “manufacturing science”
3
An Approach for Quality – Risk Connection
Concept of Quality by Design (QbD)
Product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches
Characteristics important to desired performance must be derived from a combination of prior knowledge and experimental assessment during product development.
From this knowledge and data, a multivariate model linking product and process measurements and desired attributes may be constructed.
Clinical study would then be viewed as confirmatory performance testing of the model.
Woodcock, 2004
4
A Systems Approach
CMC Reveiw
CGMP Investigations
Science of Design
Manufacturing Science
Deliver
Quality by Design
State of Control &
Continuous Improvement
5
Quality can not be tested into a product; it has to be by design