Common use of MANUFACTURE AND QUALITY CONTROL Clause in Contracts

MANUFACTURE AND QUALITY CONTROL. 5.1 The Supplier is responsible for the purchase, receipt, testing, storage, release and overall quality of all Raw Materials in accordance with the terms and conditions of this QA Agreement. 5.2 The Supplier shall perform its obligations in this QA Agreement with reasonable skill and care in accordance with best practice and standards in the Supplier's industry or trade and in accordance with all applicable laws and regulations. 5.3 The Supplier is responsible for and shall undertake a quality assessment of key vendors of Critical and Raw Materials. Critical and Raw Materials shall only be sourced from third parties who have been evaluated and approved by the Supplier in accordance with its written internal requirements. 5.4 The Supplier shall control and release the Raw Materials according to written test procedures and specifications which the Supplier shall maintain and keep current. 5.5 The Supplier shall ensure that the Material is manufactured, controlled and supplied in accordance with applicable regulations, standards and guidelines as defined in Annex 3. 5.6 During the manufacture of the Material, Supplier shall perform in-process and release control testing in accordance with written and internally approved methods and specifications. 5.7 The Supplier shall ensure that no materials from animal origin shall be used in the manufacture of Material unless certified as TSE (Transmissible Spongiform Encephalopathies) risk free by the appropriate agency or authority. 5.8 The Supplier shall ensure that all equipment used in or in connection with the manufacture and testing of the Material is qualified, calibrated and maintained as appropriate in accordance with applicable regulations, standards and guidelines as defined in Annex 3. 5.9 The Supplier shall ensure that at all times there will be a sufficient number of personnel engaged in the manufacture of the Material with a suitable level of skill, qualification and experience.