Manufacturing Documentation definition
Manufacturing Documentation means all documents and records describing or otherwise related to the Manufacturing Process, other than those embodied in the Master Production Record.
Manufacturing Documentation means all executed batch records and all deviation reports and investigation reports associated with each individual Batch Run.
Manufacturing Documentation means, with respect to a Licensed Product, the Drug Master File for such Licensed Product, and any other documentation that is necessary for the manufacture of Licensed Product (or any component thereof), including the following: manufacturing process validation reports; manufacturing instructions; batch record templates; manufacturing standard operating procedures; specifications and test methods for the Licensed Product, raw materials and stability; standard operating procedures and specifications for packaging, manufacturing and packaging instructions; master formula; validation reports (analytical, packaging and cleaning); stability data; approved supplier lists.
Examples of Manufacturing Documentation in a sentence
Client may also request scanned or printed copies of such Manufacturing Documentation, but shall be responsible for reasonable costs associated therewith.
SBL shall maintain all such Manufacturing Documentation for at least that period specified in the applicable QAG.
Notwithstanding the licenses granted in this Article VII, Trikon shall have no obligation to deliver any Software, Manufacturing Documentation or other tangible items to Aviza except as provided in Article II and Section 4.4.
SBL shall maintain Manufacturing Documentation to be true and accurate, and shall keep in strict confidence and shall not use for purposes other than providing or performing the Service or other obligations hereunder.
Supplier will invoice Company (in USD $) for the CCA intermediate and Compound produced during pilot plant or validation lot operations upon providing documentation to the Company as set forth in Paragraph 6a, Manufacturing Documentation.
More Definitions of Manufacturing Documentation
Manufacturing Documentation means data acquired and generated, documents and records describing or otherwise related to the Manufacturing Process including, without limitation: documents and records consisting of or containing process descriptions, requirements and specifications; Client Materials and Specifications; analytical methods, process trend and variability data; validations protocols and reports; process development reports; Batch Records; Batch Related Documents, and SOPs, including, without limitation, SOP’s for the Raw Materials handling, the Manufacturing operations, equipment operation, in-process, final Product and stability quality control testing, quality assurance, validation, storage and shipping.
Manufacturing Documentation has the meaning specified in Section 4.4.
Manufacturing Documentation means with respect to a given Product, the data acquired and generated, documents and records describing or otherwise related to the Manufacturing Process including, without limitation: documents and records consisting of or containing process descriptions, requirements and specifications; Client Materials and Specifications; analytical methods, process trend and variability data; validations protocols and reports; process development reports; Batch Records; Batch Related Documents, and SOPs, including, without limitation, SOP’s for the Raw Materials handling, the Manufacturing operations, equipment operation, in-process, final Product and stability quality control testing, quality assurance, validation, storage and shipping.
Manufacturing Documentation means any and all of the following that are specific to and necessary for the manufacture of Bulk Product and Finished US Goods: manufacturing process validation reports; manufacturing instructions; batch record templates; manufacturing standard operating procedures; specifications and test methods for Bulk Product and Finished US Goods, raw materials and stability; standard operating procedures and specifications for packaging and packaging instructions; master formula; validation reports (analytical, packaging and cleaning); stability data; and approved supplier lists.
Manufacturing Documentation means any and all documentation that is under the possession or control of Kadmon (or any of its Affiliates or Third Party contractors) for the manufacture of the Product (or any component thereof) for sale in the Territory, including the following: manufacturing and packaging instructions; batch record templates; analytical test methods and specifications for the Product, raw materials, manufacturing, packaging, cleaning and stability; development reports supporting manufacturing and Product formulation; validation reports (manufacturing process, analytical, packaging and cleaning); standard operating procedures; master formula; stability data; purification; formulation; filling; finishing; labeling; shipping and holding of the Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance, and quality control and interacting with regulatory authorities regarding any of the foregoing; reference standard information; approved supplier lists; and notebooks whether paper or electronic, including the Manufacturing Documentation owned by Kadmon that is listed on Schedule 1.51 — Part A (“Owned Manufacturing Documentation”) and the Manufacturing Documentation owned by any of Kadmon’s Third Party suppliers (“Third Party Supplier Manufacturing Documentation”) that is comprised of those documents listed on Schedule 1.51 — Part B plus other Manufacturing Documentation. Notwithstanding the foregoing, Manufacturing Documentation shall not include any Drug Master File held by a Third Party manufacturer of the Compound.
Manufacturing Documentation means all manufacturing procedures, formulations, tooling, drawings, design output, validation, specifications, manufacturing and testing procedures, protocols and process recipes, bills of material, parts lists, vendor lists, Software, mechanical and electrical drawings, quality control procedures and data, vendor lists, terms or agreements with Third Party suppliers and vendors, and manufacturing equipment documentation and other information, instructions or documentation necessary or useful to manufacture the Gen 1 Product or the Gen 2 Product including but not limited to the Gen 1 Product Hardware, the Sensor Disposables and the Accessories.
Manufacturing Documentation means all data, documents and records describing or otherwise related to the Manufacturing Process (or any part thereof) provided to SurModics by or on behalf of GNE or provided to GNE by or on behalf of SurModics as required by, and in connection with, this MSA or the Quality Agreement [*].