Common use of Laboratory Qualification Clause in Contracts

Laboratory Qualification. Fresenius is responsible for ensuring that all laboratories are in compliance with applicable cGMP guidelines. In addition, if analytical work is subcontracted by Fresenius, then Fresenius will perform an audit on such contract laboratories to be used for analytical testing. Fresenius will be responsible for ensuring that the vendors are practicing within cGMP compliance. In the event that TransMedics Quality Assurance laboratories will perform analytical testing of a PRODUCT, Fresenius will cooperate in the technology transfer to such laboratory, and will confirm that the technology transfer has been successful and the laboratory is capable of reproducing Fresenius laboratory results.