Batch or lot definition

Batch or lot means a single run of Product processed by a single execution of the instructions specified in the Batch Production and Control Record within the meaning of 21 CFR part 210.3(b)(2) and/or within the meaning of 21 CFR part 600.3(x), or its successor as in effect from time to time.
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Batch or lot means the hemp products produced during a period indicated by a specific code. (E) "Controlled substance" has the same meaning as found in section 3719.01 of the Revised Code.
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Batch or lot means a defined quantity of pharmaceutical products processed in a single process or series of processes so that it is expected to be homogeneous.
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Examples of Batch or lot in a sentence

  • Tube or thief sample is one obtained with a sampling tube or special thief, either as a core, or spot sample, from a specified point in the container.b. Batch or lot sample is one obtained from a collection of units of package products.5.14.2.5 Sampling apparatus, containers, and procedures.a. Approved type samplers shall be used as specified by ASTM/API procedures.

  • If the material being ordered has shelf life requirements or limitations, the following data shall be furnished by the Seller with each shipment:• Cure Date• Batch or lot number• Shelf life limitations (i.e. recommended shelf life and/or use by date in years or expiration date by “Quarter Year”).

  • Batch or lot number Each container shall be printed or permanently marked.

  • Batch (or lot): A defined quantity of starting material, packaging material or finished product processed in one process or series of processes so that it could be expected as homogeneous.

  • Provide the Engineer the following information for each shipment of hydrated lime: Letter of certification, Production date, Shipment date, Shipment destination, Batch or lot number and Net weight.

  • Batch (or lot): A defined quantity of starting material, packaging material or bulk, intermediate or finished product that is intended or purported to be homogeneous in character and quality, and which has been produced during a defined cycle of manufacture.

  • Apex completed line-cutting of a new grid over the Shaft Zone and East Zone, this grid was cut from November 8 to November 17, 2010, by CCIC.

  • It shows that Kadima attracted voters from both right-wing and left-wing political homes.

  • Be sure each test substance container has the following information written on it:• Chemical name• Expiration date• Batch or lot number• Storage conditions• IR-4 Study ID number 3.

  • Batch or lot number Any package or container not so marked will not be accepted for use under this Specification.


More Definitions of Batch or lot

Batch or lot means a quantity of:
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Batch or lot. A specific quantity of a drug or other material 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. Quality Control Master Document (QCMD)/Certificate of Analysis (COA): The Quality Control Master Document is equivalent to a Certificate of Analysis is the listing of all tests performed to release a batch and the results. Deviation: Event in the manufacturing process, testing and/or support system that is outside of approved operating parameters, the Product license, approved procedures, policies, standards, or specifications, or a departure from accepted cGMP’s.
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Batch or lot means a defined quantity of starting material, packaging material, or finish product processed in a single process or series of processes so that it could be expected to be homogeneous in the case of continuous manufacture the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity, and to complete certain stages of manufacture it may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to from a final homogeneous batch;
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Batch or lot means a defined quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. (Refer to ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients)
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Batch or lot means a specific quantity of a finished product or other material 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.
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Related to Batch or lot

  • Harvest lot means a specifically identified quantity of marijuana that is, cultivated utilizing the same growing practices and harvested within a 72 hour period at the same location and cured under uniform conditions.

  • Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

  • 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.

  • Finished Lots means, Entitled Land (i) that has been legally subdivided for the construction of Housing Units, (ii) that has been graded substantially in accordance with all grading plans approved by the applicable agencies and contains level building pads (except for any fine or precise grading to be completed immediately prior to vertical construction), (iii) that has all water, sewer, electrical and other utility services for planned residences installed and stubbed to the lot behind the sidewalk, (iv) that has all storm drain, sewer, curb, gutter, sidewalk and pavement for public access constructed and installed, except for any final lift of the streets and lateral connections to Housing Units, (v) that has all property corners surveyed and marked and any required survey monumentation installed, and (vi) with respect to which all applicable development fees (including, without limitation, school and development impact fees) that are required to be paid prior to obtaining a building permit have been paid other than building permit and plan check fees. Except as otherwise expressly provided in this Agreement, the term “Finished Lot” shall not include any Land upon which the construction of a Housing Unit has commenced.

  • Cluster development means a contiguous cluster or

  • 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.

  • 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.

  • Manufactured dwelling park means a place where four or more manufactured dwellings

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Batch Record means the production record pertaining to a 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.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Master plumber means an individual who possesses the necessary skills and qualifications to plan and supervise the installation of plumbing and who is licensed as a master plumber.

  • Structural component means a component that supports non-variable forces or weights (dead loads) and variable forces or weights (live loads).

  • Combustion turbine means an enclosed fossil or other fuel-fired device that is comprised of a compressor, a combustor, and a turbine, and in which the flue gas resulting from the combustion of fuel in the combustor passes through the turbine, rotating the turbine.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Certified Remanufacture System or Verified Engine Upgrade means engine upgrades certified or verified by EPA or CARB to achieve a reduction in emissions.

  • 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.

  • Diatomaceous earth filtration means a process resulting in substantial particulate removal in which a precoat cake of diatomaceous earth filter media is deposited on a support membrane (septum), and while the water is filtered by passing through the cake on the septum, additional filter media known as body feed is continuously added to the feed water to maintain the permeability of the filter cake.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • Phase I Environmental Site Assessment means a Phase I environmental property assessment of the Assets that satisfies the basic assessment requirements set forth under the current ASTM International Standard Practice for Environmental Site Assessments (Designation E1527-13) or any other visual site assessment or review of records, reports or documents.