Division of Responsibilities Table Sample Clauses

Division of Responsibilities Table. Responsibilities Not Applicable Client Supplier 1. General Provisions 1.01 Follow applicable current Good Manufacturing Practices (cGMPs), including International Conference on Harmonization (ICH) Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (API)) and locally imposed requirements. X 1.02 Manufacture, package, ship, store and test the Product and materials in an environment meeting the applicable GMP regulations, which is designed, constructed and maintained in a manner that a) permits the operation therein to be performed under clean, sanitary and orderly conditions; b) permits the effective cleaning of pertinent surfaces; and c) prevents the contamination of the Product and the addition of extraneous material to the Product. X 1.03 Manufacture the Product in adherence to applicable regulatory submissions, such as Drug Master File (DMF), if applicable. X 1.04 Operate in compliance with applicable environmental, occupational health and safety laws and regulations. X