Common use of Quality Controls Clause in Contracts

Quality Controls. Both Parties shall institute quality controls in accordance with, and shall comply with, applicable laws and regulations and generally accepted industry standards (including cGMPs as defined below) for the manufacture, storage, shipment, handling and distribution of the Compound, the Product and the Finished Product (as the case may be) and shall define responsibilities for key quality systems and a quality manual agreed to by both Parties (including without limitation, Sample Packs) and shall comply with all applicable laws and regulations relating to the storage, shipment, handling and distribution of the Compound, the Product and the Finished Product. Each Party shall have the right to audit all facilities used by the other Party to fulfill their obligations under this Agreement (including any Third Party manufacturing facilities). For the purposes of this Agreement, "cGMPs" means all applicable standards relating to manufacturing practices for intermediates, bulk products, or finished pharmaceutical products (i) promulgated in the form of laws or regulations by the FDA or its counterpart governmental agencies or entities in the EU and/ or a country in the International Territory or (ii) promulgated by the FDA or its counterpart governmental agencies or entities in the EU and/ or a country in the International Territory in the form of guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines) which guidance documents are being implemented within the pharmaceutical manufacturing industry for such products.

Quality Controls. Both Parties shall institute quality controls in accordance with, and shall comply with, applicable laws and regulations and generally accepted industry standards (including cGMPs CGMPs as defined below) for the manufacture, storage, shipment, handling and distribution of the Compound, the Product and the Finished Product (as the case may be) and shall define responsibilities for key quality systems and a quality manual agreed to by both Parties (including without limitation, Sample Packs) and shall comply with all applicable laws and regulations relating to the storage, shipment, handling and distribution of the Compound, the Product and the Finished Product. Each Party shall have the right to audit all facilities used by the other Party to fulfill their obligations under this Agreement (including any Third Party manufacturing facilities). For the purposes of this Agreement, "cGMPsCGMPs" means all applicable standards relating to manufacturing practices for intermediates, bulk products, or finished pharmaceutical products (i) promulgated in the form of laws or regulations by the FDA or its counterpart governmental agencies or entities in the EU and/ or a country in the International Territory or (ii) promulgated by the FDA or its counterpart governmental agencies or entities in the EU and/ or a country in the International Territory in the form of guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines) which guidance documents are being implemented within the pharmaceutical manufacturing industry for such products.