GMP Batch definition

GMP Batch means a Batch that is intended to meet cGMP requirements.
GMP Batch means a Batch that is intended to meet GMP requirements.
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.

Examples of GMP Batch in a sentence

  • Accordingly, a major thrust of this section of the report is to describe the investments required to create a system of social care support that will enable everyone in Scotland to get the social care support they need to live their lives as they choose and that promotes and ensures human rights, wellbeing, independent living and equity.

  • 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.

  • Our proprietary audio signal processing technologies, including Distributed Echo Cancellation®, have been the core of our professional conferencing products and are the foundation for our new product development in other conferencing categories.

  • Tekmira shall be responsible for ensuring that all of the Facilities meet the agreed upon regulatory standards indicated in each GMP Batch Work Order at all relevant times.

  • No later than the first Business Day of each Calendar Quarter, Alnylam shall provide Tekmira with a GMP Batch Forecast of Alnylam’s anticipated requirements for GMP Batch production under this Agreement, covering the Calendar Quarter in which such GMP Batch Forecast is so delivered and the following seven (7) Calendar Quarters.

  • Tekmira will also be responsible for ensuring that all such qualifications and/or validations have been performed in the case of all other Facilities or equipment, to the extent involved in the Manufacture of any GMP Batch.

  • 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.

  • Provider shall reduce the payment due under this Section 9.5 by a sum equal to the fee received by the third party customer (after accounting for out-of-pocket costs incurred by Provider to accomplish such mitigation) for the costs of Provider’s labor and equipment that Provider would have expended on manufacturing Synthorx’s non-cGMP or GMP Batch, as the case may be.

  • Except as specified in a SOW or any Quality Agreement executed hereunder, prior to the delivery of any Batch of Biologic to Client, CMO shall provide Client with (a) a Certificate of Analysis for such Batch and (b) if such Batch is a GMP Batch, a Certificate of Compliance.

  • Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology.


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.
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.
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.
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.
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.
GMP Batch means: a Batch that meets the Release Specifications, and is manufactured under GMP, in all material respects.

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 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.

  • 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.

  • 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 the American Petroleum Institute.

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

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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 thereof.

  • 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 those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • 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.