title: Transfer of analytical procedures: a panel of strategies selected for risk management, with emphasis on an integrated equivalence-based comparative testing approach.
abstract: In 2001, a multidisciplinary team made of analytical scientists and statisticians at Sanofi-aventis has published a methodology which has governed, from that time, the transfers from R&D sites to Manufacturing sites of the release monographs. This article provides an overview of the recent adaptations brought to this original methodology taking advantage of our experience and the new regulatory framework, and, in particular, the risk management perspective introduced by ICH Q9. Although some alternate strategies have been introduced in our practices, the comparative testing one, based equivalence testing as statistical approach, remains the standard for assays lying on very critical quality attributes. This is conducted with the concern to control the most important consumer's risk involved at two levels in analytical decisions in the frame of transfer studies: risk, for the receiving laboratory, to take poor release decisions with the analytical method and risk, for the sending laboratory, to accredit such a receiving laboratory on account of its insufficient performances with the method. Among the enhancements to the comparative studies, the manuscript presents the process settled within our company for a better integration of the transfer study into the method life-cycle, just as proposals of generic acceptance criteria and designs for assay and related substances methods. While maintaining rigor and selectivity of the original approach, these improvements tend towards an increased efficiency in the transfer operations.
authors.affiliation: Biostatistics, Research & CMC, Sanofi-aventis, 195 Route d'Espagne, 31036 Toulouse, France. christophe.agut@sanofi-aventis.com
authors.forename: C
authors.initials: C
authors.lastname: Agut
authors.forename: A
authors.initials: A
authors.lastname: Caron
authors.forename: C
authors.initials: C
authors.lastname: Giordano
authors.forename: D
authors.initials: D
authors.lastname: Hoffman
authors.forename: A
authors.initials: A
authors.lastname: Ségalini
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000592:standards; D003257:Consumer Product Safety; D055808:Drug Discovery / Q000592:standards; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D017408:Guidelines as Topic; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000138:chemical synthesis / Q000592:standards; D011786:Quality Control; D012308:Risk Management / Q000592:standards; D018511:Systems Integration; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations