Conforming Batch definition

Conforming Batch means a Batch which both Dyax's and Xxxxxxxxxx'x quality assurance groups have determined to have met the following requirements: (i) has been produced in accordance with cGMP; (ii) meets the Drug Substance or Drug Product Specification; (iii) adheres to all applicable laws; and (iv) which has been produced in accordance with the Manufacturing Description.
Sample 1
Conforming Batch a cGMP Batch which has been produced in accordance with cGMP, and which meets the Product Specification;
Sample 1Sample 2
Conforming Batch means a Batch that was made in accordance with agreed-upon Batch records, the Work Order, and, where applicable, cGMP.
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Examples of Conforming Batch in a sentence

  • If, based upon such tests and documentation review, Provider determines that a Batch is a Conforming Batch, then the Batch documentation for each Batch of drug substance or drug product will be delivered to Synthorx by an agreed upon courier.

  • In the event Synthorx discovers a Latent Defect in a Batch after Synthorx previously accepted such Batch as a Conforming Batch pursuant to paragraphs (d) or (e) of this Section, Synthorx will have one month from the date of acceptance of that Batch to reject such Batch because of the Latent Defect.

  • If Synthorx does not notify Provider within the applicable time period that the Batch does not conform to the Work Order or cGMP (if applicable), then Synthorx will have accepted the Batch as a Conforming Batch and waived its right to revoke acceptance, and the drug substance or drug product must be deemed a conforming Synthorx Product.

  • Each Batch will be sampled and tested by Provider in accordance to the approved Batch record, and Provider will review the documentation to assess if the Batch is a Conforming Batch.

  • Synthorx will notify Provider in writing of its acceptance or rejection of such Conforming Batch within […***…] of receipt of the complete Batch documentation relating to such Batch.

  • It is understood that only NCRs and OOS which have an adverse effect on the quality of Product will be taken into consideration in determining whether a Batch is a Conforming Batch or a Non-Conforming Batch.

  • Conforming Batch shall not be Delivered to Dyax, unless Dyax requests it.

  • A Batch which; after review of the Disposition Package, is deemed by both Dyax’s and Fujifilm’s quality assurance groups to not meet the requirements of a Conforming Batch.


More Definitions of Conforming Batch

Conforming Batch means a Batch which meets the following requirements: (i) has been produced in accordance with CGMP; (ii) meets the Drug Product Specification; (iii) adheres to all applicable laws; and (iv) has been produced in accordance with the Master Batch Record.
Sample 1Sample 2
Conforming Batch a Batch of Product which has been produced in accordance with cGMP and which meets the Product Specification and a Batch of Intermediate Product [***] which has been produced in accordance with cGMP and which meets the [***] Reagent Specification or the Intermediate Product Specification, as applicable; Fujifilm Ascendis Commercial Supply Agreement 2
Sample 1
Conforming Batch means a cGMP Batch which (a) has been produced in accordance with cGMP; and (b) meets the Final Product Specifications in the applicable Work Order and/or QC Document.
Sample 1

Related to Conforming Batch

  • Nonconforming sign means a sign or sign structure, other than a nonstandard sign or a sign that is erected and maintained in a business area along a scenic byway prior to the designation as a scenic byway, that satisfies 1 of the following:

  • Nonconforming Goods means only the following: (i) product shipped is different than identified in Buyer's purchase order; or (ii) product's label or packaging incorrectly identifies its contents.

  • Non-Conforming Product means a Product that does not conform to the Supplier’s Warranties.

  • Conforming means goods or performance under a lease contract that are in accordance with the obligations under the lease contract.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Nonconforming lot means a lot that met dimensional requirements of the applicable master program at the time of its establishment but now contains less than the required width, depth or area due to subsequent changes to the master program.

  • Nonconforming use means a use of land that:

  • Nonconforming structure means a structure the size, dimension

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Batch Record means the production record pertaining to a Batch.

  • Nonconformity or “Nonconformities” means any failure or failures of the Software to conform to the requirements of this Contract, including any applicable Documentation.

  • Nonconforming zoning condition means a physical improvement on a property that does not conform with current zoning standards.

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

  • 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;

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

  • Nonconformance as used in this clause means a condition of any hardware, software, material, or service/workmanship in which one or more characteristics do not conform to requirements.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • 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.

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

  • Defective Product has the meaning set forth in Section 5.2.

  • non-conforming use means a lawful specific use:

  • Product Warranty has the meaning set forth in Section 9.3.

  • 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.

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

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.