GMP Development Process Sample Clauses

The GMP Development Process clause outlines the procedures and standards required for developing products or materials in accordance with Good Manufacturing Practice (GMP) guidelines. It typically details the steps involved in product development, such as documentation, quality control, and compliance checks, ensuring that all processes meet regulatory requirements. This clause is essential for maintaining product safety and quality, and it helps organizations demonstrate compliance with industry regulations, thereby reducing the risk of regulatory violations or product recalls.
GMP Development Process. Design Professional shall deliver to Construction Manager on or before the date set forth in the Project Schedule, the GMP Drawings and Specifications and the Design Professional’s Statement of Incomplete Documents, for the applicable Deliverable Portion of Work (collectively, the “GMP Documents”). Owner Parties and Construction Manager shall include in the GMP Documents, Work that shall be priced, scheduled, and included in the Contract Documents, as an Alternate, and Work that shall be priced, scheduled, and included in the Contract Documents, as an Allowance. The Alternate Schedule shall include the required start dates for each Alternate, and the sequencing priority of implementing each Alternate. Within fourteen (14) Days after receipt of the GMP Documents and in accordance with the Project Schedule, Construction Manager shall submit to Owner Parties its proposed GMP and its proposed GMP Qualifications and Assumptions (collectively, the “GMP Proposal”), all based upon the applicable GMP Documents, on the form GMP Amendment attached as Exhibit D. Construction Manager acknowledges and agrees the GMP Drawings and Specifications may require further substantial development at the time Construction Manager prepares its GMP Proposal, and that its GMP Proposal takes into account such further development. Construction Manager shall include in each such GMP Proposal, Alternate pricing and Allowance pricing, applicable to the Deliverable Portion of Work for which the GMP Proposal is issued. By including an Allowance in a GMP Proposal, Construction Manager represents and warrants it is a reasonable estimate of the Cost of the Work of such Allowance, based on Construction Manager’s best skill and judgment, based on Drawings and Specifications that are sufficiently detailed to make such an estimate. Each Alternate’s and Allowance’s pricing shall remain valid from the date Construction Manager issues its final GMP Proposal through the date of Final Completion of the applicable Deliverable Portion of Work containing each such Alternate or Allowance unless, in the case of an Allowance, Construction Manager develops a final price for that portion of the Work included in such Allowance, in which case that final price shall remain valid through the date of Final Completion of the applicable Deliverable Portion of Work. Within ten (10) Days after Construction Manager delivers a GMP Proposal, Construction Manager shall submit to Owner Parties its Work plan for the applicab...
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Related to GMP Development Process

  • Design Development Phase 1.3.1 Based on the approved Schematic Design Documents, model(s) and any adjustments to the Program of Requirements, BIM Execution Plan or Amount Available for the Construction Contract authorized by the Owner, the Architect/Engineer shall prepare, for approval by the Owner and review by the Construction Manager, Design Development Documents derived from the model(s) in accordance with Owner’s written requirements to further define and finalize the size and character of the Project in accordance with the BIM Execution Plan, “Facility Design Guidelines” and any additional requirements set forth in Article 15. The Architect/Engineer shall review the Design Development documents as they are being modeled at intervals appropriate to the progress of the Project with the Owner and Construction Manager at the Project site or other location specified by Owner in the State of Texas. The Architect/Engineer shall utilize the model(s) to support the review process during Design Development. The Architect/Engineer shall allow the Construction Manager to utilize the information uploaded into Owner’s PMIS to assist the Construction Manager in fulfilling its responsibilities to the Owner. 1.3.2 As a part of Design Development Phase, Architect/Engineer shall accomplish model coordination, aggregation and “clash detection” to remove conflicts in design between systems, structures and components. Architect/Engineer shall utilize Owner’s PMIS to accomplish model coordination and collaborate with Construction Manager in the resolution of critical clashes identified by the Construction Manager. Architect/Engineer shall demonstrate and provide written assurance to Owner that conflicts/collisions between models have been resolved. 1.3.3 The Architect/Engineer shall review the Estimated Construction Cost prepared by the Construction Manager, and shall provide written comments. 1.3.4 Before proceeding into the Construction Document Phase, the Architect/Engineer shall obtain Owner’s written acceptance of the Design Development documents and approval of the mutually established Amount Available for the Construction Contract and schedule. 1.3.5 The Architect/Engineer shall prepare presentation materials including an animation derived from the model(s) as defined in “Facility Design Guidelines” at completion of Design Development and if so requested shall present same to the Board of Regents at a regular meeting where scheduled within the state. 1.3.6 The Architect/Engineer shall prepare preliminary recommended furniture layouts for all spaces where it is deemed important to substantiate the fulfillment of program space requirements, or to coordinate with specific architectural, mechanical and electrical elements. 1.3.7 Architect/Engineer shall assist the Owner, if requested, with seeking approval of the Project by the Texas Higher Education Coordinating Board (THECB). Such assistance shall include (i) the preparation of a listing of the rooms and square footages in the Project, and (ii) the preparation of project cost information, in accordance with THECB Guidelines. This information shall be provided at the completion of the Design Development Phase when requested by the Owner. The listing of rooms and square footages shall then be updated to reflect any changes occurring during construction and provided to the Owner at Substantial Completion. 1.3.8 At the completion of the Design Development Phase, or such other time as Owner may specify to Architect/Engineer, at Owner’s sole option and discretion, Owner will furnish Architect/Engineer with a Guaranteed Maximum Price proposal prepared by Construction Manager based upon the Design Development documents prepared by the Architect/Engineer and approved by the Owner. The Architect/Engineer shall assist the Owner and endeavor to further and advocate the Owner’s interests in Owner’s communications with the Construction Manager in an effort to develop a Guaranteed Maximum Price proposal acceptable to Owner, in Owner’s sole option and discretion. If the Owner does not accept the Construction Manager’s Guaranteed Maximum Price proposal, the Architect/Engineer shall participate with the Owner and Construction Manager in constructability reviews and shall revise the documents as necessary in order to reach an agreement. If the Construction Manager’s Guaranteed Maximum Price proposal exceeds the Schematic Design Phase Estimated Construction Cost prepared by, or otherwise accepted by the Construction Manager due to an increase in the scope of the Project caused by further development of the design documents by the Architect/Engineer to the extent that such could not be reasonably inferred by the Construction Manager from the Schematic Design documents, and Owner directs Architect/Engineer to revise the documents, the Architect/Engineer shall revise the documents at its own expense so that the Guaranteed Maximum Price proposal for constructing the Project shall not exceed the Owner’s Amount Available for the Construction Contract and any previously approved Estimated Construction Costs. If it is determined to be in the Owner’s best interest, instead of requiring the Architect/Engineer to revise the Drawings and Specifications, the Owner reserves the right to accept a Guaranteed Maximum Price proposal that exceeds the stipulated Amount Available for the Construction Contract. The Architect/Engineer shall analyze the final Guaranteed Maximum Price proposal document, together with its supporting assumptions, clarifications, and contingencies, and shall submit a detailed written analysis of the document to the Owner. Such analysis shall include, without limitation, reference to and explanation of any inaccurate or improper assumptions and clarifications. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the Owner’s rejection of the Guaranteed Maximum Price proposal is not due to a failure of the A/E to provide the services otherwise required herein. 1.3.9 After the Guaranteed Maximum Price has been accepted, the Architect/Engineer shall incorporate necessary revisions into the Design Development documents. The A/E will not be required to make revisions to the documents at its own expense under the provisions of this paragraph if the revisions are required as the result of inaccurate assumptions and clarifications made in the development of the Guaranteed Maximum Price proposal that are not due to a failure of the A/E to provide the services otherwise required herein.

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  • Program Development NWESD agrees that priority in the development of new applications services by WSIPC shall be in accordance with the expressed direction of the WSIPC Board of Directors operating under their bylaws.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.