Transfer of Analytical Procedures
Frank Böttcher and Timo Krebsbach
Labor L+S AG, Bad Bocklet-Großenbrach, Germany
Correspondence: Dr. Frank Böttcher, Labor L+S AG, Mangelsfeld 4, 97708 Bad Bocklet-Großenbrach, Germany, e-mail: firstname.lastname@example.org
Pharmaceutical companies contract tests for drug product release to a greater extent to specialized laboratories. As a consequence, an analytical method transfer is needed to efficiently maintain the quality control of the active drug substance or drug product. When validated methods are transferred between laboratories their validated state must be maintained to ensure the same reliable results in the receiving laboratory. The transfer of the analytical procedure can occur in different ways depending e. g. on the know-how of the giving laboratory and the receiving laboratory as well as the kind of the test method. Currently there is no definition for the transfer of analytical procedures in terms of an official guideline. In this article the general aspects of an analytical method transfer as well as some practical examples dealing with the transfer of chemical/physical as well as microbiological methods are described.
Key words Contract analysis • Contract laboratory • Know-how transfer • Method transfer • Outsourcing
pharmind 2011, Nr. 1, Seite 152