Validated Manufacturing Process definition

Validated Manufacturing Process means the manufacturing process for Product that is established after the completion of Processing, at scale, of the Validation Batches in accordance with the Manufacturing Standards.
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Validated Manufacturing Process means AMRI - Leon’s successful execution of a mutually agreed validation protocol and manufacture of such number of batches as agreed in the validation protocol, at scale, that have been processed to conform to applicable product specifications. Customer acknowledges that a change in product specifications, the manufacturing process or master batch records may require a new Validated Manufacturing Process using the new product specifications, manufacturing process or master batch records.
Sample 1
Validated Manufacturing Process means AMRI’s manufacture of an appropriate number of successful cGMP batches and in no event less than three consecutive cGMP batches at scale and at the same specification for a particular Product. Changes to specifications may require a new validation.
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Examples of Validated Manufacturing Process in a sentence

  • Notwithstanding anything in this Agreement to the contrary, Customer shall pay for all failed batches of product in accordance with the applicable Proposal and assumes responsibility for all costs, including but not limited to the cost of API or other Customer materials, associated with batch failures until such time as there exists a Validated Manufacturing Process for a particular product.

  • In 2004, through Dutch funding, the programme placed at the centre of its strategy the development of SES indicators database, and PSS and ELFS.

  • Customer acknowledges that a change in product specifications, the manufacturing process or master batch records may require a new Validated Manufacturing Process using the new product specifications, manufacturing process or master batch records.

  • Customer assumes responsibility for all costs associated with batch failure(s) until such time as there exists a Validated Manufacturing Process for a particular Product.

  • Except in the case of AMRI - Leon’s gross negligence, Customer shall pay for all failed batches of product and assumes responsibility for all costs, including but not limited to the cost of API, other Customer-supplied materials or other raw materials associated with batch failures until such time as there exists a Validated Manufacturing Process for a particular product.

Related to Validated Manufacturing Process

  • Manufacturing Process means any process for—

  • 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.

  • 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 Site means a location where a manufacturing

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

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

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

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

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

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • 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.

  • 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;

  • Distillery manufacturing license means a license issued in accordance with

  • API means American Petroleum Institute.

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

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

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

  • 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;

  • 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 Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • 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.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.