San Francisco, California
London, United Kingdom
The Southern California Pharmaceutical Discussion Group (SCPDG) announces:
Lifecycle Management of Analytical Procedures; What is it all about?
Sponsored by: Waters
When: Thursday, May 8, 2014 at 6:00 PM
Where: Courtyard Marriott, 8 MacArthur Place, Santa Ana, CA 92707
Agenda: 6:00-6:30 PM networking, 6:30-7:15 PM dinner, 7:15-8:30 PM presentation and discussion..
Registration: Please register via the Eventbrite link below by May 5, 2014
Attendance is by pre-registration only – no walk-ins please.
Registration fee includes dinner, parking and presentation. A cash bar is available but not included.
Working Professional (includes consultants)- $50
Working Professional/AAPS member-$40
Student (full-time)/ Retired/ Unemployed (no consultants) - $15
Abstract:In the Stimuli article Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification, the USP Validation and Verification Expert Panel discusses how the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures.
Rather than being viewed as separate entities, the Expert Panel proposes that the traditional approaches to validation, transfer, and verification should be integrated into the analytical procedure lifecycle process. As a starting point, the requirements for a measurement of a critical quality attribute are established in the Analytical Target Profile. In alignment with process validation, three stages are proposed: Procedure Design (development and understanding), Procedure Performance Qualification, and Continued Procedure Performance Verification.
A key concept is the use of a Decision Rule to describe how the results will be applied. The Decision Rule gives a prescription for the acceptance or rejection of a product based on the measurement result, its uncertainty, and acceptance criteria, taking into account the acceptable level of the probability of making a wrong decision. Using this Decision Rule, we calculate the target measurement uncertainty, which is the maximum uncertainty that the data should have in order to maintain acceptable levels of confidence in data quality. The target measurement uncertainty becomes part of the Analytical Target Profile and is used to determine the key performance characteristics required of the method and drive the method design and qualification.
The concept of Quality by Design (QbD) is understood as a “systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management” (ICH Q8). Application of lifecycle management concepts to analytical procedures provides an opportunity to use the knowledge gained from the application of scientific approaches and quality risk management to continual improvement and assurance of data quality. This QbD concept is based on the method being fit for use and the reportable result from the method being fit-for-its-intended-use. This will result in better measurements and better decisions being made using these results. For example, the analytical variability will be known so that it can be separated from manufacturing variability, allowing each to be more effectively controlled.
Biography: Jane Weitzel has been working in analytical chemistry for over 35 years in with the last 5 years at the director/associate director level in the pharmaceutical industry. She is currently a full time consultant and auditor, as well as a volunteer and trainer for the USP. Jane has applied Quality Systems and statistical techniques, including the estimation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.
For the 2010 – 2015 cycle, Jane is a member of the USP Reference Standards committee and Expert Panel on Method Validation and Verification. She was appointed to the Chinese National Institute for Drug and Food Control Reference Standards Committee for 2013 to 2016.
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