Validation Master Plan definition

Validation Master Plan means a document that summarises the firm’s overall philosophy,
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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.
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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.
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Examples of Validation Master Plan in a sentence

  • The key principles of qualification and validation program were defined and documented in the Validation Master Plan.

  • Introduction: Definition of Qualification and Validation, Advantage of Validation, Streamlining of Qualification & Validation process and Validation Master Plan.

  • Course Outcome: Upon completion of the subject student shall be able to• Explain the aspect of validation• Carryout validation of manufacturing processes• Apply the knowledge of validation to instruments and equipments• Validate the manufacturing facilities UNIT - IIntroduction: Definition of Qualification and Validation, Advantage of Validation, Streamlining of Qualification & Validation process and Validation Master Plan.

  • Course Outcome: Upon completion of the subject student shall be able to Explain the aspect of validation Carryout validation of manufacturing processes Apply the knowledge of validation to instruments and equipments UNIT IIntroduction: Definition of Qualification and Validation, Advantage of Validation, Streamlining of Qualification & Validation process and Validation Master Plan.

  • Members of the Damien Memorial School community must remember that when telecommunicating with individuals, groups, or institutions, one does so as an individual.

  • The key elements of a qualification and validation program were defined and documented in the Validation Master Plan (VMP).

  • Validation is performed, and records maintained, as per the Validation Master Plan SOP G5807.

  • One (1) contaminated unit is considered cause for revalidation, following an investigation.’” When filling 5,000 to 10,000 units, according to Dr. Reddy’s Validation Master Plan, “[o]ne (1) contaminated unit is considered cause for an investigation based on which a [redacted] revalidated run can be planned.

  • The FDA noted that investigations into deviations were woefully inadequate in comparison to Dr. Reddy’s own Validation Master Plan.

  • Despite the requirements in Dr. Reddy’s Validation Master Plan, the FDA pointed out that Dr. Reddy’s did not determine assignable cause for numerous batches with high numbers of rejected units, well beyond the threshold of one or two rejected units per media fill.


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. Advaxis - IDT Manufacturing Services Agreement Execution Counterpart Acronyms
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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.
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Related to Validation Master Plan

  • 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.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Project Implementation Manual or “PIM” means the manual setting out the measures required for the implementation of the Project, as the same may be amended from time to time, subject to prior approval of the Association;

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • 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.

  • 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.

  • 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.

  • 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.

  • Decommissioning Plan means the document containing detailed information on the proposed decommissioning and covering the following: the selected decommissioning strategy; the schedule, type and sequence of decommissioning activities; the waste management strategy applied, including clearance; the proposed end state; the storage and disposal of the waste from decommissioning; the timeframe for decommissioning; the cost estimates for the completion of decommissioning; and the objectives, expected results, milestones, target dates, as well as the corresponding key performance indicators, including, as appropriate, earned value based indicators. The plan is prepared by the nuclear facility license holder and is reflected in the multiannual work programmes of the Programme;

  • 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).

  • Improvement Plan means the plan required by the Authority from the Supplier which shall detail how the Supplier will improve the provision of the Goods and/or Services pursuant to Clause 29.1.1 (Authority Remedies);

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

  • Training Plan means the plan that outlines what training and assessment will be conducted off-the-job and what will be conducted on-the-job and how the Registered Training Organisation will assist in ensuring the integrity of both aspects of the training and assessment process.

  • Participating Prescription Drug Provider means an independent retail Pharmacy, chain of retail Pharmacies, mail-order Pharmacy or specialty drug Pharmacy which has entered into an agreement to provide pharmaceutical services to participants in the benefit program. A retail Participating Pharmacy may or may not be a select Participating Pharmacy as that term is used in the Vaccinations Obtained Through Participating Pharmacies section.

  • Prescription monitoring program means the electronic system within the Department of Health Professions that monitors the dispensing of certain controlled substances.

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

  • Approved abuse education training program means a training program using a curriculum approved by the abuse education review panel of the department of public health or a training program offered by a hospital, a professional organization for physicians, or the department of human services, the department of education, an area education agency, a school district, the Iowa law enforcement academy, an Iowa college or university, or a similar state agency.

  • 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.

  • Treatment program means an abstinence based program or facility that is accredited by any of the following:

  • Development Plan has the meaning set forth in Section 3.2.

  • Treatment plan means a written agreement between the department and the parent or

  • Technology Transfer Plan will have the meaning set forth in Section 4.1.

  • Project Implementation means all steps which the Grantee undertakes in order to deliver the Project which is being supported by funding provided under this Grant Contract. Any reference to UK primary legislation (Acts) or secondary legislation (Statutory Instruments) in this Grant Contract includes reference to any changes to or replacement of those Acts or Statutory Instruments.

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

  • 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;