Production Records definition
Examples of Production Records in a sentence
Should CBSW need to create additional Master Production Records as the result of commencement of Phase II or the production of Product in the Custom Production Suite, CBSW will prepare such additional Master Production Records under the terms and conditions set forth in Section 5.
CBSW will prepare and Client will cooperate in the preparation of all Master Production Records for each Process developed or implemented by CBSW pursuant to this Agreement.
Master Production Records (MPRs) are documents that specify or reference the manufacturing instructions, related bills of material, in process testing, and production specifications used in the production process.
Based on the Client Production Materials, CBSW will prepare Master Production Records for Fresh Product and Cryopreserved Product under the terms and conditions set forth in Section 5.
Upon request, Contractor shall provide CO and COR with the following contract funded documents as specified below but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard Operating Procedures (SOP’s), Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports.
All Production Records related to the Manufacturing of Vector Product shall be owned by Company and archived with SAFC after Manufacturing for a period as stated in the Quality Agreement.
Those documents requiring initial Customer approval and approval by Customer of any changes are as follows: Product Specification Master Production Records Raw Material Specifications When Customer initiates a change request on all applicable specifications, the appropriate BVL department shall be provided the proposed specification and appropriate documentation that summarizes and justifies each change.
Production Records Facility and production records must be maintained including, but not limited to, pest control, receiving and inspection, batch records, processing, weight control, calibration, sanitation audits and procedures, and training.
CBL will permit TKT to review all information in Master Production Records pertaining to individual product lots as well as, raw material test results and the results of environmental monitoring prior to product release by CBL but after CBL’s completion of its internal review of the batch record.
The arbitral tribunal reaches its decision on the basis of the provisions of this Agreement as well as on the principles and norms of international law.