Manufacturing SOPs definition

Manufacturing SOPs means, with respect to a particular Finished Product being supplied by Arena to Eisai under Article 6, the specific methods, techniques, processes and standard operating procedures (including Quality Control Procedures) that are used by or on behalf of Arena in manufacturing such Finished Product.
Manufacturing SOPs means, with respect to a particular Product being supplied by Arena to Eisai under this Agreement, the specific methods, techniques, processes and standard operating procedures (including Quality Control Procedures) that are used by or on behalf of Arena in manufacturing such Product.
Manufacturing SOPs means the specific methods, techniques, processes and standard operating procedures that are to be used by Biocon in Manufacturing Clinical Material under this Agreement.

Examples of Manufacturing SOPs in a sentence

  • Arena shall ensure that all Finished Product supplied to Eisai hereunder by Arena shall be manufactured in accordance with the applicable Manufacturing SOPs, the Quality Agreement, GMP and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall conform to the applicable warranty set forth in Section 6.13.

  • Novasep shall store and handle all Product as required by the applicable Manufacturing SOPs, cGMP, and all established safety practices for the Product.

  • Spending time in India helping teachers to introduce physical education into the primary school curriculum.

  • Upon Equillium’s written request, Biocon shall provide to Equillium copies of the complete Master Batch Records and specific Manufacturing SOPs and updates as defined in the Quality Agreement, copies of the relevant documents identifying any Biocon technology used in the Manufacture of Clinical Material under the Manufacturing SOPs, and all CMC Data.

  • Any actual costs incurred by Novasep in making changes to the Manufacturing Process or the Manufacturing SOPs that are requested by Celladon shall be reimbursed by Celladon, in amounts to be agreed by the parties in writing prior to performing such changes.

  • Without limiting the generality of the foregoing, upon Celladon’s written request, Novasep shall provide to Celladon all documents specified in the Quality Agreement, including, by way of example only, the complete Master Batch Records and specific Manufacturing SOPs and updates as defined in the Quality Agreement, copies of executed, completed Batch Records for each Batch, and all relevant documents relating to the Manufacturing Process or any Novasep Project IP used in manufacturing Product.

  • Arena shall ensure that all Product supplied to Eisai or the applicable Designated Distributor hereunder by Arena shall be manufactured in accordance with the applicable Manufacturing SOPs, the applicable Quality Agreement, GMP and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall conform to the applicable warranty set forth in Section 12.2.

  • Any such technology transfer pursuant to this Section 8.4 shall include the Master Batch Records, Manufacturing SOPs, Quality Control Procedures, the design of the Modified Novasep Facility, and all necessary portions of the Novasep Project IP used by Novasep in the manufacture of Product.

  • Subject to Section 5.3, Arena shall label and package (in appropriate primary, secondary and tertiary packaging), including production of Package Inserts, Product to be supplied in accordance with such agreement of the Parties, the applicable Manufacturing SOPs, and Applicable Laws of each applicable country in the Territory, for delivery to Eisai or the Designated Distributor under this Agreement.

  • No changes to the Specifications, the Manufacturing SOPs or the Master Batch Records shall be made except in accordance with the change control procedures of the Quality Agreement.


More Definitions of Manufacturing SOPs

Manufacturing SOPs means the specific methods, techniques, processes and standard operating procedures that are to be used by Novasep to manufacture Product, including the applicable Quality Control Procedures.
Manufacturing SOPs means, WITH RESPECT TO A PARTICULAR PRODUCT BEING SUPPLIED BY ARENA TO EISAI UNDER THI Agreement, THE SPECIFIC METHODS, TECHNIQUES, PROCESSES AND STANDARD OPERATING PROCEDURES (INCLUDING QUALITY CONTROL PROCEDURES) T are used by or on behalf of Arena in manufacturing such Product.
Manufacturing SOPs means, as to a Product, the specific methods, techniques, processes and standard operating procedures that are to be used by AMAG or a DSS to Manufacture Drug Product, Drug Product Intermediate and/or Drug Substance.
Manufacturing SOPs means, as to a particular Bulk Product Component, the specific methods, techniques, processes and standard operating procedures that are to be used by Lonza to manufacture such Bulk Product Component, including the applicable Quality Control Procedures applicable to such Bulk Product Component.
Manufacturing SOPs means the specific methods, techniques, processes and standard operating procedures that are to be used by PolyPeptide to manufacture API, including the applicable Quality Control Procedures applicable to the API.

Related to Manufacturing SOPs

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Manufacturing Process means any process for—

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • API means the American Petroleum Institute.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.