Batch certification. 7.6.1. After detailed review of the batch documentation of each batch, GW is responsible to ensure that a Certificate of Compliance with GMP (CoC, confirmation statement) is included or attached to the CoA, Deviation Statement if applicable, that is signed by a Quality Assurance person (Qualified Person). 7.6.2. A copy of one complete Batch Record shall be sent to NOVARTIS annually and upon request.
Appears in 3 contracts
Sources: Manufacturing and Supply Agreement, Manufacturing and Supply Agreement (Gw Pharmaceuticals PLC), Manufacturing and Supply Agreement (Gw Pharmaceuticals PLC)