GMP Manufacturing definition

GMP Manufacturing means all processes and activities typically engaged in by a person or entity in the pharmaceutical or medical device industry for the GMP manufacture of a product or component thereof, including procuring raw materials, manufacturing, quality control and assurance testing, GMP record keeping, packaging and labeling.
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Examples of GMP Manufacturing in a sentence

  • During manufacturing of the GMP Batches, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the GMP Manufacturing Process for the purpose of observing and reporting on the performance of the Services.

  • For clarity, a request to reschedule Services will not be considered a Cancellation Notice, and rescheduling of GMP Manufacturing Services will be subject to Section 5.6 (Rescheduling or Reduction of Services).

  • GSK's assessment and suggestions with respect to enhancements and capacity expansion of Manufacturing of Drug Product in the GMP Manufacturing Facility will be according to GSK's best understanding at that time of the applicable requirements, practice and quality standards.

  • The FTE Rate is “fully burdened” and will cover employee salaries, benefits, travel, and such facilities and equipment and other materials and services including ordinary laboratory and Manufacturing consumables (like, for example, growth media, but not larger out-of-pocket expenses that are used in GMP Manufacturing of a Compound, such as chromatography resins) procured from distributors of relevant products as they may use.

  • With respect to GMP Manufacturing Services, to the extent Reservation Fees have not been specified in the relevant SoW, Provider shall notify Senti of the Reservation Fees applicable to: (i) the first three (3) months of the rolling Services Forecast, and each subsequent three (3) month period of the rolling Services Forecast thereafter, or (ii) such period for use of a dedicated suite indicated in the Suite Forecast, or as otherwise agreed between the Parties in writing.

  • Upon, or as soon as practicable after the Parties’ entry into a SoW and for each month thereafter, Senti shall provide Provider with a rolling twelve (12)-month forecast of Senti’s requirement for (a) GMP Manufacturing Services to be provided under the SoW (“Services Forecast”), and/or (b) the use of a dedicated suite within the Facility (the “Suite Forecast”).

  • Exelixis will inform BMS as to the GMP Manufacturing and testing site of bulk drug substance for the Exelixis Compound, as well as the Exelixis Compound drug product GMP Manufacturing and testing site, prior to the start of the Combined Therapy Trials and provide [ * ] advance written notice of any change to these site(s).

  • CureVac and its Affiliates will reserve the required capacity for the Manufacture of Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s).

  • To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of COVID Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s).

  • Consistent with this mission, MdBio has instituted its GMP Manufacturing Incentive Program (the "Program"), whereby MdBio invests in bioscience enterprises for the specific purpose of having the proceeds of such investment used for the manufacture, under GMP-compliant conditions, of bioscience products within the state of Maryland.

Related to GMP Manufacturing

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Manufacturing Process means any process for—

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.