title: The transfer of analytical procedures.
abstract: Analytical method transfers are certainly among the most discussed topics in the GMP regulated sector. However, they are surprisingly little regulated in detail. General information is provided by USP, WHO, and ISPE in particular. Most recently, the EU emphasized the importance of analytical transfer by including it in their draft of the revised GMP Guideline. In this article, an overview and comparison of these guidelines is provided. The key to success for method transfers is the excellent communication between sending and receiving unit. In order to facilitate this communication, procedures, flow charts and checklists for responsibilities, success factors, transfer categories, the transfer plan and report, strategies in case of failed transfers, tables with acceptance limits are provided here, together with a comprehensive glossary. Potential pitfalls are described such that they can be avoided. In order to assure an efficient and sustainable transfer of analytical procedures, a practically relevant and scientifically sound evaluation with corresponding acceptance criteria is crucial. Various strategies and statistical tools such as significance tests, absolute acceptance criteria, and equivalence tests are thoroughly descibed and compared in detail giving examples. Significance tests should be avoided. The success criterion is not statistical significance, but rather analytical relevance. Depending on a risk assessment of the analytical procedure in question, statistical equivalence tests are recommended, because they include both, a practically relevant acceptance limit and a direct control of the statistical risks. However, for lower risk procedures, a simple comparison of the transfer performance parameters to absolute limits is also regarded as sufficient.
authors: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
authors: J
authors: J
authors: Ermer
authors: M
authors: M
authors: Limberger
authors: K
authors: K
authors: Lis
authors: H
authors: H
authors: Wätzig
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods*; D017408:Guidelines as Topic; D011786:Quality Control; D018581:Technology Transfer; D014944:World Health Organization
keywords: Absolute acceptance criteria; Analytical; Equivalence test; Method transfer; Success factor