Validation Master Plan definition

Validation Master Plan means a document that summarises the firm’s overall philosophy,
View Source
Validation Master Plan means a high level written strategy for the overall setup, installation, operation and/or performance of various parameters critical to the lifecycle of the PRODUCT, COMPONENT, TEST METHOD or PROCESS. InterMune/Catalent - KY Quality Agreement Confidential [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
View Source
Validation Master Plan means a document that is approved by both Parties that describes specific activities necessary to accomplish qualification of processes specific for manufacture of the Product to cGMP standards.
View Source

Examples of Validation Master Plan in a sentence

  • The equipment will be qualified by the Purchaser according to the Purchasers current Qualification/ Validation Master Plan including System Impact Assessment.

  • After review by Sandoz and mutual agreement by both parties on the final Process Validation Master Plan, Sandoz will prepare a draft Process Validation Protocol.

  • Development of a draft Validation Master Plan specific to the Commercial Facility - cGMP audit of the facility design - Assist in the development of Factory Acceptance Test (FAT) plans (by vendors); witness FATs - Development and execution of Installation Qualification(IQ) protocols - Development of the Site Acceptance Test (SAT) plan; witness SATs - Review of the commissioning plan.

  • EZEM must maintain a Validation Master Plan to describe the commitment to perform the validation of its facility and processes with cGMP and to maintain control over all systems and processes already validated.

  • June 15th 2004 In order to ensure that the process can be validated for later commercialisation the necessary work will be carried out in fully characterising the performance of the critical parameters, identified during initial phases of T7P3 and the means by which those parameters will be monitored to generate the required plan of activities in validating the process, the Validation Master Plan.

  • Prior to the completion of Preliminary Engineering, the draft Validation Master Plan will be prepared and submitted for ImClone approval.

  • The Validation Lead will oversee the preparation of the draft Validation Master Plan and will issue it to ImClone for approval.

  • ACHAOGEN and HOVIONE acknowledge that the Process Validation will be separately completed for each process step as defined in the Validation Master Plan, thereby resulting in a separate validation report for each step.

  • The Development Project Team shall have the authority to make minor changes to the Validation Master Plan, and make recommendations to the Parties as to subsequent changes to the Validation Master Plan.

  • Quality Agreement Master Batch Records Quality Control Document Quality Control Test Methods Process Description Validation Master Plan [*] = CONFIDENTIAL TREATMENT REQUEST(ED).


More Definitions of Validation Master Plan

Validation Master Plan means a document detailing the equipment, systems or Processes to be qualified or validated, defining the Services to be performed, the approach to be used, the responsibility Party for such Services, and a timeline for the Services.
View Source
Validation Master Plan means a document defining the scope of validation work including equipment/systems or processes to be validated and the overall validation approach.
View Source