Process Validation Report definition

Process Validation Report means a report delivered by BioVectra to Keryx containing information that confirms adherence to the Process Validation Protocol.
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Process Validation Report means a written report prepared by RPS in consultation with CTI evidencing the repeatability of Compound quality and stability over the production of [**] Compound batches, as required for commercial release of the Compound under applicable Government Approvals, and all Validations and the achievement of any other production validation criteria so required and as the Parties shall mutually agree, and which report shall, subject to Section 10.6, be attached hereto at Annex 10 upon completion and sign off, in writing, by both Parties. 1.30 Validation Schedule and Timeline Shall mean the schedule of work and timelines for the Validations and the manufacture by RPS of Phase 1 validation batches of Compound, described at Annex 3 hereto. 1.31 Validation Success Criteria Shall mean the criteria agreed between the parties for the Validations and the successful completion of the manufacture by RPS of validation batches of Compound, as set forth in the Validation Schedule and Timeline. 1.32 Vendors Shall mean any and all Third Party suppliers of materials, processing services and/or testing services engaged by RPS in connection with this Agreement. 2.0
Sample 1
Process Validation Report means a document that provides a detailed account of the approach, intentions, and activities to be conducted during a validation activity and the results and findings from avalidation activity.
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Examples of Process Validation Report in a sentence

  • Further, the foregoing price shall be inclusive of the cost of the Process Validation Report and all validation batches, excluding the cost of the milling part of the Validations to the extent any milling is done by a Third Party, in which case, the cost of such milling by a Third Party shall be the sole responsibility of CTI.


More Definitions of Process Validation Report

Process Validation Report means a written report prepared by RPS in consultation with CTI evidencing the repeatability of Compound quality and stability over the production of [**] Compound batches, as required for commercial release of the Compound under applicable Government Approvals, and all Validations and the achievement of any other production validation criteria so required and as the Parties shall mutually agree, and which report shall, subject to Section 10.6, be attached hereto at Annex 10 upon completion and sign off, in writing, by both Parties.
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Related to Process Validation Report

  • Verification Report As defined in Section 4.19.

  • Inspection Report means the report delivered by the Master Servicer or the Special Servicer, as the case may be, substantially in the form of Exhibit L hereto.

  • Evaluation Report means a report on the evaluation of tenders prepared under CSO 12

  • Batch Record means the production record pertaining to a Batch.

  • CEC Certification and Verification means that the CEC has certified (or, with respect to periods before the Project has commenced commercial operation (as such term is defined by and according to the CEC), that the CEC has pre-certified) that the Project is an ERR for purposes of the California Renewables Portfolio Standard and that all Energy produced by the Project qualifies as generation from an ERR for purposes of the Project.

  • Home inspection report means a written report that is

  • Exception Report As defined in the Custodial Agreement.

  • Collection Report means the monthly report prepared by the Primary Servicer setting forth, with respect to each Mortgage Loan and the most recently ended Collection Period prior to the due date of such report, the information described on Exhibit G attached hereto.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

  • Acceptance Tests means those tests performed during the Performance Period which are intended to determine compliance of Equipment and Software with the specifications and all other Attachments incorporated herein by reference and to determine the reliability of the Equipment.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Transaction Report is that certain report of transactions and schedule of collections in the form attached hereto as Exhibit C.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Condition Report means a condition report with respect to a Group III Vehicle, signed and dated by a Lessee or a Franchisee and any Manufacturer or its agent in accordance with the applicable Vehicle Disposition Program.

  • Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • Locational Deliverability Area Reliability Requirement means the projected internal capacity in the Locational Deliverability Area plus the Capacity Emergency Transfer Objective for the Delivery Year, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, less the minimum internal resources required for all FRR Entities in such Locational Deliverability Area.

  • Project Report means a summary statement of the likely environmental effects of a proposed development referred to in section 58;