Introduction/Objective of the Course:

Current GMP requirements for test method validation are quite clear: Methods used for GMP product testing must be validated to demonstrate they can produce accurate and reliable results. But FDA and EU guidances are less clear about method ‘validation’ during product development. On the one hand, they indicate method validation is an evolving process, but on the other they state that method validation data should be available upon request at Phase II and Phase III. These guidances also indicate that test methods only need to be qualified for Phase I (except safety methods, which do require validation prior to Phase I). Methods used only for product or process characterization, comparability or similarity also need to be qualified to demonstrate they are scientifically sound. Some of these methods will start out in non-GMP labs then transfer to GMP labs; others will only ever be used in non-GMP labs. But during development, even data generated in non-GMP studies are critical for making process and product decisions, and are reported in product dossiers as supportive information. Although there is guidance on lab data integrity in GMP labs, there are no current guidance documents on data integrity in non-GMP labs.

The Seminar Will Cover:

• Overview of ICH, FDA and EU guidance documents associated with method validation and data integrity for in-house and contract testing labs
• Outline of types of test methods typically used with biotech/biosimilar products for characterization, comparability, similarity, release and stability testing
• Illustration of typical method lifecycle events for test methods (optimization, qualification, validation, method changes, method transfer, method replacement)
• Differences in study designs between qualification, validation, verification, tech transfer and bridging for biotech/biosimilar products
• Overview of data integrity expectations for GMP analytical testing labs
• Risks to data from non-GMP R&D labs at each phase of development and for key CMC analytical studies
• Illustration of best-practices for lab quality and data integrity for non-GMP R&D labs

About the Instructor:

Nadine Ritter obtained her master and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 years. She entered the biopharm industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for diagnostic product submissions, responded to FDA comments, contributed to compliance remediation efforts for QC inspection observations, and led the ISO9000 certification of the R&D analytical lab.