cGMP Contract definition

cGMP Contract means a contract between the Customer and Baxter, in form and substance satisfactory to Baxter, complying with the requirements of The Therapeutic Goods Act 1989 (Cth) and The Therapeutic Goods Regulations 1990 (Cth), Schedule 5A or the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods Part 1: Manufacture of Pharmaceutical Products administered by Medsafe (as applicable);

Examples of cGMP Contract in a sentence

  • Basic cGMP Contract Responsibilities ○ Shall maintain a Quality Department, Quality System, and manufacturing operations to be in compliance with cGMP requirements; ○ Shall manufacture, test and supply cGMP Batches of Product and cGMP Services to be in compliance with cGMP requirements ○ Shall test Drug Product as defined in the BMA Exhibit 1, Annex 2.