Master Validation Plan definition

Master Validation Plan means the program mutually agreed to by the parties by which documented evidence provides assurance that the Process will consistently produce BMIPP that meets Specifications.
Sample 1Sample 2Sample 3
Master Validation Plan means a written plan stating how facilities, systems, and equipment (including control software) will be validated to provide a high degree of assurance that they are fit for use in pharmaceutical production
Sample 1Sample 2
Master Validation Plan means the program established by Nordion by which documented evidence provides a high degree of assurance that the Isotope will consistently be produced to meet Specifications.
Sample 1Sample 2

Examples of Master Validation Plan in a sentence

  • Prior to implementation, both parties shall in writing approve the Master Validation Plan.

  • Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance.

  • The monetary base, which comprises banknote circulation and the sight deposits of the commercial banks at the Swiss National Bank, expanded much more markedly than expected.

  • The costs of preparation, development and implementation of the Master Validation Plan will be borne by Nordion.

  • After the Facility is completed, Nordion shall, in consultation with Molecular Insight Pharmaceuticals, develop and implement a Master Validation Plan for the Facility that will allow the production of BMIPP under cGMPs in the volumes required by Molecular Insight Pharmaceuticals for Phase III clinical supply as described in Section 4.1. The costs of preparation, development and implementation of the Master Validation Plan will be borne by Nordion.

  • Created the validation process (Master Validation Plan), setup the validation team and wrote validation protocols.• Re-designed two user interfaces to work with touch screen and mouse.

  • After the Facility is established, Nordion agrees, in consultation with BLSI, to develop and implement a Master Validation Plan for the Facility that will allow the production of Altropane under cGMPs to those volumes required by BLSI, not to exceed the Maximum Batch Size.

  • Nordion shall, in consultation with Molecular Insight Pharmaceuticals, develop and implement a Master Validation Plan that will allow the production of Azedra under cGMPs for Clinical Trial supply and for Commercial Phase supply.

  • Nordion shall generate all necessary cGMP documentation relating to the production of Isotope; procure, test, and release all raw materials relating to the Isotope; validate all necessary process equipment, and perform all necessary process validation according to the Master Validation Plan, which Master Validation Plan shall be prepared by Nordion.

  • Orphan shall pay to CORD an Information Systems Development Fee equal to ***, which will include installation of a communications line, all activities required to make the Information System operational for Orphan, reasonable user training, a reasonable number of copies of the System documentation and a copy of the Master Validation Plan.


More Definitions of Master Validation Plan

Master Validation Plan means the program by which documented evidence provides assurance that the Process will consistently produce Azedra that meets Specifications.
Sample 1Sample 2
Master Validation Plan means the program mutually agreed to by the parties by which documented evidence provides assurance that the Process will consistently produce Altropane that meets Specifications.
Sample 1Sample 2
Master Validation Plan means the program by which documented evidence provides assurance that the Process will consistently produce [123I]NAV5001 that meets Specifications.
Sample 1

Related to Master Validation Plan

  • Implementation Plan means the schedule included in the Statement of Work setting forth the sequence of events for the performance of Services under the Statement of Work, including the Milestones and Milestone Dates.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • State implementation plan or “SIP” means the plan adopted by the state of Iowa and approved by the Administrator which provides for implementation, maintenance, and enforcement of such primary and secondary ambient air quality standards as they are adopted by the Administrator, pursuant to the Act.

  • Indicators of student progress and growth means the results of assessment(s) of students as defined in N.J.A.C. 6A:8, Standards and Assessment.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Transition Plan means a transition plan, acceptable to the LHIN that indicates how the needs of the HSP’s clients will be met following the termination of this Agreement and how the transition of the clients to new service providers will be effected in a timely manner; and

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Source Protection Plan means a drinking water source protection plan prepared under the Clean Water Act, 2006;

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Supply Plan has the meaning set forth in the CAISO Tariff.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Rectification Plan means the rectification plan pursuant to the Rectification Plan Process;

  • Master Plan means a subcontracting plan that contains all the required elements of an individual contract plan, except goals, and may be incorporated into individual contract plans, provided the master plan has been approved.

  • Master subcontracting plan means a subcontracting plan that contains all the required elements of an individual subcontracting plan, except goals, and may be incorporated into individual subcontracting plans, provided the master subcontracting plan has been approved.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Redevelopment Plan means the “Lincoln Center Redevelopment Plan” passed, adopted and approved by the City pursuant to the Resolution, and shall include any amendment of said Redevelopment Plan heretofore or hereafter made by the City pursuant to law.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • EHC plan means an Education, Health and Care plan made under sections 37(2) of the Children and Families Act 2014.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Support Plan means a service offering that sets out the level of service entitlements purchased by Customer as described in detail in the Agreement.

  • Utilization plan means a form and additional documentation included in all bids or proposals that demonstrates a vendor’s proposed utilization of vendors certified by the Business Enterprise Program to meet the targeted goal. The Utilization Plan shall demonstrate that the Vendor has either: (1) met the entire contract goal or (2) requested a full or partial waiver and made Good Faith Efforts towards meeting the goal.

  • Implementation Grant means payments towards Recurrent Expenditure incurred for the establishment of the Academy prior to it opening.

  • Compliance Plan means the compliance obligations, program, and procedures described in this Consent Decree at paragraph 13.

  • layout plan means a plan of the project depicting the division or proposed division of land into plots, roads, open spaces, amenities, etc. and other details as may be necessary;

  • Action Plan means an action plan as defined in the AEP Regulations in relation to the Premises;]