Validation Master Plan Clause Samples
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Validation Master Plan. HOVIONE and ACHAOGEN acknowledge that they will agree, in writing, on a validation master plan setting out the Process Validation activities to be conducted by HOVIONE under this Agreement (the “Validation Master Plan”). The process validation shall not commence until ACHAOGEN and HOVIONE confirm in writing that the Validation Master Plan is acceptable.
Validation Master Plan. The PARTIES shall agree on a VALIDATION master plan which shall establish the priorities and timetable for validating all critical systems, processes, tests and equipment, among other things. Consideration shall be given to whether currently validated systems, processes and tests need to be re-validated by BI Austria. Based on the VALIDATION master plan, individual VALIDATION protocols shall be created.
Validation Master Plan. 12.1.1 The SUBCONTRACTOR will have and maintain a Validation Master Plan that identifies critical equipment, systems and processes used to manufacture, test and evaluate product, and the requirements for validation and revalidation.
Validation Master Plan. Prior to the completion of Preliminary Engineering, the draft Validation Master Plan will be prepared and submitted for ImClone approval.