Master Production Records. 5.5.1 C*P may transcribe the manufacturing information (i.e., formulation, filing work order, packaging work order) into its own format and may obtain written approval from ORPHAN for each document version before manufacturing. However, agreed upon changes to documentation will be handled as outlined by Change Management (see section 10) of this agreement.
Master Production Records. 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.
Master Production Records. 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. These documents are developed and approved by BVL and Customer. Customer’s approval of the MPR must be received at least eight (8) weeks prior to the start of manufacture.
Master Production Records. 6 5.6 Standard Operating Procedures......................... 6 5.7
Master Production Records. DSM may transcribe the manufacturing information (i.e., formulation, filling work order, packaging work order, etc.) into its own format and shall obtain written approval from Barrier for each document version before manufacturing. Mutually agreed changes to documentation will be handled as outlined by Change Management (see Section 10) of this agreement.
Master Production Records. Master Production Records will be developed and approved by CBSB and Tercica. Tercica’s approval of the MPR must be received at least [*] prior to the start of a Run. * This provision is the subject of a Confidential Treatment Request.
Master Production Records. Nastech shall have appropriate Master Batch Records that meet cGMPs and instructions adequate to ensure that each lot manufactured using the Master Batch Records will meet cGMPs.
Master Production Records. Master Production Records will be handled as outlined under Change Management in Section 10 of this Agreement.
Master Production Records. Specifications for active and inactive materials and primary packaging components. - Specifications for intermediates, and finished bulk and packaged finished product. - Analytical methods. - Process validation protocols and final reports. - Equipment cleaning validation protocols and final reports. - Facility cleaning validation protocols and final reports. - Analytical method validation protocols and reports. - Utility (e.g., HVAC, water) validation protocols and reports. - Equipment installation qualification and operational qualification protocols and reports. - Audit reports for suppliers of active, critical intermediates, inactive materials, and primary packing components. - Audit reports for contract testing facilities, packagers/labelers, etc. - Trend analysis reports. - Customer complaint records and investigation reports. - GMP Annual Product Reviews. - Analytical method and process technology transfer reports. - Standard Operating Procedures. - Stability protocols and reports for bulk active, intermediates, bulk finished and packaged product. - Shipping study protocols and reports. - In vitro dissolution profiles. - Calibration Records. - Change Control records and reports (process, equipment, facility, etc.).
Master Production Records. LONZA may transcribe the manufacturing information (i.e., bulk manufacturing) into its own fonnat and will obtain written approval from ORPHAN for major changes to the process before manufacturing. Additionally Lonza will provide Orphan with all changes to process documentation, analytical methods, and specifications. Agreed upon changes to documentation will be handled as outlined by Change Management (see Section 10) of this agreement. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX H
