Technical transfer of testing methods
Article 37
1. Prior to transferring a test method, the transferring site shall verify that the test method complies with the terms of the marketing authorisation and relevant regulatory requirements. 2. The transfer of testing methods from one laboratory (transferring laboratory) to another laboratory (receiving laboratory) shall be described in a detailed protocol. 3. The protocol shall include, among others, the following elements: (a) identification of the testing to be performed and the relevant test method undergoing transfer; (b) identification of any specific training requirements; (c) identification of standards and samples to be tested; (d) identification of any special transport and storage conditions of test items; (e) the acceptance criteria. 4. Deviations from the protocol shall be investigated prior to the closure of the technical transfer process. The technical transfer report shall document the comparative outcome of the process and shall identify areas requiring further test method revalidation, if applicable.