Batch Release definition

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 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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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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Examples of Batch Release in a sentence

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

  • This shall demonstrate that the batch of medicinal product has been examined and tested by an OMCL within the Union (EEA) in accordance with this procedure and with Official Control Authority Batch Release guidelines pertaining to the medicinal product and that it is in compliance with the approved specifications laid down in the relevant monographs of the European Pharmacopoeia (Ph. Eur.) and in the relevant marketing authorisation.

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

  • For products subject to Official Control Authority Batch Release (OCABR) this activity needs to be conducted by a designated OMCL located in the Union (EEA) or a country covered by a mutual recognition agreement that includes recognition of OCABR.

  • 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.

  • 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.

  • The CTSU’s issue of the Certificate of Analysis (CofA) for the Bulk Formulated Product and the Pack Batch Release Certificate of the finished drug product, is considered the “Technical Green Light” for the IMP to be released.

  • The CTSU must also provide the CSC or designee with Certificate of Analysis (CofA) and the Pack Batch Release Certificate for each batch of an IMP supplied which is considered the technical green light.

  • Official Control Authority Batch Release (OCABR): Requirement by a Party, as referred to and regulated by pharmaceutical legislation and guidelines of the Community and the Council of Europe and Israel, that an Official Medicines Control Laboratory determines the conformity of a batch with the approved specifications as laid down in the marketing authorisation before the competent authority of the Party will allow that batch to be marketed.

  • This is referred to as Official Control Authority Batch Release (OCABR).According to the EU Administrative Procedure for Official Control Authority Batch Release13, prior to marketing in the Union (EEA), batches of medicinal products subject to independent testing should obtain an Official Control Authority Batch Release Certificate common to all Member States.


More Definitions of Batch Release

Batch Release means the release of gaseous or liquid effluent of a discrete volume.
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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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Related to Batch Release

  • Work release means a program of partial confinement

  • New Release means new releases, updates or versions of the Software made generally available by SAP through unrestricted shipment pursuant to SAP Support after the Effective Date of the Agreement.

  • 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 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.

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

  • Product Specification means the document referred to in:

  • 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 A Release Agreement as defined in Section 3.05 of the Servicing Agreement.

  • 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 U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.

  • 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 a minor update or upgrade to the Software (including service releases or bug fixes), identified by Bosch by a change in the second or following digit in the release number (e.g. change from version 2.1 to 2.2 or 2.2.1 to 2.2.2.).