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 the specific methods, techniques, processes and standard operating procedures that are to be used by Biocon in Manufacturing Clinical Material under this Agreement.
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.

Examples of Manufacturing SOPs in a sentence

  • The OCR SOP template footer sets forth the following elements: SOP Number (Center Footer):o Standard Operating Procedure (SOP) for Writing SOPs: 000o Sponsor SOPs: 001 to 099 Serieso Manufacturing SOPs: 100 to 199 Serieso Compliance and Site Operations SOPs: 200 to 299 Serieso Finance SOPs: 300 to 399 Serieso System and Training SOPs: 400 to 499 Series Effective Date/Revised Date: Date of the SOP or Date of SOP revision. Version No.: The version as displayed in the version control section.

  • 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.


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 Finished Product being supplied by Arena to Roivant under Article 6 and the Compound contained therein, the specific methods, techniques, processes and standard operating procedures (including Quality Control Procedures) that are established in accordance with the Quality Agreement and are used by or on behalf of Arena in manufacturing such Finished Product or such Compound.
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 PolyPeptide to manufacture API, including the applicable Quality Control Procedures applicable to the API.
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.

Related to Manufacturing SOPs

  • Manufacturing Site means a location where a manufacturing

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

  • 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, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • 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 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 Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • 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, 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:

  • Distillery manufacturing license means a license issued in accordance with

  • 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 current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

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