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...