recorded on 29.04.2015
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According to cGMP regulations, analytical procedures must be designed to assure that pharmaceuticals conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160). This includes that components of these procedures such as reagents, solvents, mobile phases, and standard solutions are sufficiently controlled to maintain the required quality for an accurate testing. Therefore, appropriate instructions for preparation and storage must be established, as well as an expiry date (EU GMP Guide Part 1 Chapter 6: Quality Control and FDA Q&As on Current Good Manufacturing Practices).
This webinar will provide recommendations how to establish expiry dates of reagents and solutions used in analytical procedures. Approaches range from literature-based information to specific stability studies, according to the risk of the respective component for the accuracy of the test procedure.
What are the documentation and labelling requirements?
Which approaches are suitable to establish an expiry date?
How can a risk-evaluation be performed to justify an appropriate expiry date establishment?
Practical examples for a scientifically sound stability evaluation of solutions used in quantification.
The webinar targets executives and staff in quality control laboratories and quality assurance, who want to get an overview on GMP requirements with respect to expiry dating of chemicals, reagents, solutions, and solvents, as well as their efficient practical implementation.
Dr Joachim Ermer is Head of Quality Control Services Chemistry Frankfurt (Sanofi, Germany), and Global Reference Standards Coordinator of Sanofi. He studied biochemistry at University of Halle and has about 25 years’ experience in pharmaceutical analytics including development products, global responsibilities as Director of Analytical Processes and Technology, and Head of Quality Control. He is member of the USP Expert Panel on Validation and Verification and of the EFPIA Quality by Design working group.