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 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 all executed batch records and all deviation reports and investigation reports associated with each individual Batch Run.
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.
Manufacturing Documentation: Instructions, drawings, specifications, work orders, travelers and all other documents provided to manufacturing operators and inspectors defining the intended design, manufacturing methods, and quality controls.
During the term of this Agreement, Trikon will deliver to Aviza any and all updates to the Manufacturing Documentation that are directly relevant to the Trikon Transport Modules used by Aviza and supplied hereunder, on the same schedule as Trikon internally issues engineering changes orders for such updates.
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, 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.
Manufacturing Documentation has the meaning specified in Section 4.4.
Manufacturing Documentation means any and all documentation that is necessary, required by applicable Laws and in the possession of Sellers (or any of their respective Affiliates) for the Manufacture of the Products (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 Products, raw materials and stability; standard operating procedures and specifications for labeling, packaging, manufacturing and packaging instructions; master formula; validation reports (analytical, packaging and cleaning); stability data; and approved supplier lists.
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 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 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 [*].
Manufacturing Documentation means all design and manufacturing information relating to the manufacture of the Parts, including but not limited to the drawings, specifications, standards, processes, tooling, engineering folder, qualification data, parts lists, software and all other technical and design information as well as data utilised in the manufacture of the Parts by Endwave and that may be needed for the manufacture of the Parts (including any changes thereto) by TRW, Nokia and/or by a third party.