GMP Batch definition

GMP Batch means a Batch that is intended to meet GMP requirements.
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GMP Batch means a Batch which is identified in a Statement of Work as a GMP Batch and which is or is intended to be manufactured during a GMP Stage and subject to Disposition, all in accordance with cGMP, and “GMP Product” shall mean the Product from or in the GMP Batch.
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GMP Batch means: a Batch manufactured after the Engineering Batch and after the GMP Specifications and the GMP Procedures have been agreed, that is required to be manufactured according to the GMP Procedures in all material respects, to comply with GMP Specifications and to be manufactured in accordance with GMP in all material respects.
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Examples of GMP Batch in a sentence

  • A restorative meeting with any injured party is often beneficial to a successful reintegration and this will be discussed during the meeting.Where the exclusion was for a serious incident, a risk assessment may be carried out and discussed at the reintegration.Although it will normally not be necessary, the school reserves the right to use fixed term exclusion up to the maximum period allowed in current legislation.

  • Maintain an up-to-date list of applications for housing assistance.

  • Produced in the Clinical Manufacturing Facility; a controlled access, clean room facility that follows the GMP Phase 1 guidance recommendations and documented in GMP Batch Record documents followed by a technical review.

  • I command a diverse hands-on skill set that includes multiple formats of bioreactor platforms, primary and transformed tissue culture, scale-up and scale-down models, analytical assay development, Tech Transfer, SOPs, Process and GMP Batch record authoring, CRO/CDMO due diligence, Procurement specialist for cGMP and significant Project Management experience.

  • The Parties agree that, in the event ADVAXIS wishes to postpone or cancel (any of) the Runs (for clarification a Run can be an Engineering Batch or GMP Batch), ADVAXIS shall notify SYNCO thereof in writing as soon as possible.

  • The Parties will agree in writing on the final GMP Specifications ultimately within six (6) weeks prior to the start of the GMP Batch.

  • The investigation included review of the following processes:• GMP Batch record information was evaluated, which focused on the supply chain and chain of custody.

  • Furthermore, ADVAXIS shall reserve a Slot and pay a Reservation Fee in respect of such reservation at the latest (6) months prior to the date on which the manufacturing of a GMP Batch is scheduled as described in the applicable Service Specific Addendum.


More Definitions of GMP Batch

GMP Batch means a Batch of Biologic supplied, or to be supplied, to Client hereunder that is manufactured in accordance with GMPs that meets the Specifications in the applicable SOW or Quality Agreement.
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GMP Batch means a batch of the Active Ingredient that will be used for phase II and/or phase III clinical trials and that is manufactured in accordance with Good Manufacturing Practice.
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GMP Batch means a Batch manufactured according to GMP. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
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GMP Batch means a Batch identified in a Work Order to be manufactured in accordance with cGMP and subject to Disposition in accordance with cGMP.
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Related to GMP Batch

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

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

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

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

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

  • 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.

  • API means American Petroleum Institute.

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

  • Manufacturing Site means a location where a manufacturing

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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.

  • Manufacturing Process means any process for—

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • 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;

  • 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;

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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;

  • 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.”

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

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

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