Batch Release definition

Batch Release means the final sign-off by a party's quality department marking the culmination of the quality process through which a batch of Product is shown to conform to all aspects of the Manufacturing Standards.
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Batch Release means the final written approval, signed by NOF’s (or its subcontractor’s or CMO’s, as applicable) relevant quality assurance (“QA”)/quality control (“QC”) officer, marking the culmination of the quality process through which a Batch is shown to conform to cGMPs, the applicable Specifications, and all applicable Laws.
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Batch Release means a release of any Batch by a Qualified Person for distribution or further processing confirming that the Batch is in accordance with the relevant requirements for human use (as defined in Directive 2001/83/EC for medicinal products for human use);
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Examples of Batch Release in a sentence

  • I/we further undertake to provide the Batch Release Laboratory Test Reports of each batch of the product on its delivery.

  • I/we further under take to provide the Batch Release Laboratory Test Reports of each batch of the product on its delivery.

  • I/we further undertake to provide the Batch Release Laboratory Test Reports of each batch of the product on itsdelivery.

  • I/We further under take to provide the Batch Release Laboratory Test Reports of each batch of the product on its delivery.

  • Batch Release for each batch – copies certified with the stamp of the Supplier.

  • Deviations, Out of Specifications (OOS), Out of Trend (OOT), Complaints - evaluation and handling, Investigation and determination of root cause, Corrective & Preventive Actions (CAPA), Returns and Recalls, Vendor Qualification, Annual Product Reviews, Batch Review and Batch Release.

  • This is referred to as Official Control Authority Batch Release (OCABR).

  • We further undertake to provide the Batch Release Laboratory Test Reports of each batch of the product on its delivery.

  • EU Official Control Authority Batch Release (OCABR) certificates issued prior to 29 March 2019 would be accepted by the UK, whether they have been issued by the UK or another EU OCABR laboratory.

  • For the European Community, the official batch release procedure for medicinal products for human use is specified, in document "Administrative EC Batch Release Procedure III/3859/92" and different specific batch release procedures.


More Definitions of Batch Release

Batch Release means the final sign-off by Gensia Sicor's Quality Department marking the culmination of the quality process by which a batch of Product is shown to conform to all aspects of the Manufacturing Standards.
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Batch Release means inspection of all relevant documentation with the objective of establishing the compliance of a batch with the marketing authorisation for a medicinal product and requirements of good manufacturing practice, and providing a final assessment of the batch compliance. II. CONDITIONS FOR THE MANUFACTURE OF MEDICINAL PRODUCTS
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Batch Release means the Qualified Person (“QP”) signature on the Certificate of Analysis in Germany;
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Batch Release means the release of gaseous or liquid effluent of a discrete volume.
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Related to Batch Release

  • Work release means a program of partial confinement

  • New Release means a partial or complete replacement of the executable code of the Software in machine-readable form, which may provide new features or functions. A New Release may incorporate some or no enhancements. A New Release involves only such alterations that change the release number to the immediate right of the decimal point. Changes to the release number are made solely at the discretion of the Licensor.

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

  • SHIPPING RELEASE means the document issued by the inspector or the inspection agency nominated by the Purchaser authorising the Contractor to ship the Stores on satisfactory completion of inspection.

  • Pre-Release shall have the meaning set forth in Section 2.09.

  • Major Release means a major update or upgrade to the Software, which includes significant enhancements and/or a major redesign of the Software, identified by Bosch by a change to the first digit in the release number (e.g. change from version 2.0 to 3.0).

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • Software Release means any subsequent, generally available version of Software provided after initial Delivery of Software, but does not mean a new Product.

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

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Release Agreement means an agreement, substantially in a form approved by the Company, pursuant to which Executive releases all current or future claims, known or unknown, arising on or before the date of the release against the Company, its subsidiaries and its officers.

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • API means American Petroleum Institute.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Maintenance Release means any update, upgrade, release or other adaptation or modification of the Software, including any updated Documentation, that Contractor may generally provide to its licensees from time to time during the Term, which may contain, among other things, error corrections, enhancements, improvements or other changes to the user interface, functionality, compatibility, capabilities, performance, efficiency or quality of the Software.

  • 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.

  • 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;

  • Deed of Release has the meaning set out in the Restructuring Implementation Deed;

  • Expiry Date (Data di Scadenza) means the "Expiry Date" as specified in § 1 of the Product and Underlying Data.

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • Earned release means earned release from confinement as

  • Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Minor Release means an incremental release of Software that provides maintenance fixes and additional Software functions. Cisco designates Minor releases as a change in the tenths digit of the Software version number [x.(x).x].