Drug Substance Batch definition

Drug Substance Batch means a specific quantity of the Drug Substance that is intended to be of uniform character and quality and is produced during the same Batch Run.
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Drug Substance Batch means Drug Substance derived from [***] fermentation runs of Intermediate at [***] working volume scale producing [***] Intermediate Batches resulting in [***] of purified Drug Substance.
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Drug Substance Batch means a drug substance Batch of Product manufactured at the Facility.
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Examples of Drug Substance Batch in a sentence

  • Authorities 23 CFR 230.409 FHWA Form-1273 Types of Comprehensive Compliance Reviews NDOT performs two types of Comprehensive Compliance Reviews: project-based and contractor-based.

  • X Review and approve Raw Materials, Resins, Consumables, or Drug Substance Batch as an outcome of an approved investigation report.

  • In this case the value of the destroyed Drug Substance will be calculated by multiplying the Drug Substance Batch Fee times the grams of Drug Substance destroyed in the manufacture of the Non-Conforming Batch of Drug Product divided by the total grams of Drug Substance in the next Batch.

  • Subsequent to initial recognition, they are measured at fair value and changes therein, other than impairment losses and foreign currency differences on available- for-sale debt instruments, are recognized in other comprehensive income and presented within equity in the fair value reserve.

  • All such records shall be maintained for a period of not less than three (3) years from the date of expiration of each Drug Substance Batch to which said records pertain, or such longer period as may be required by law, rule or regulation.

  • Pharmacyclics will notify HCC of the expiration date for each Drug Substance Batch.

  • Lonza shall not be responsible for the cost of Raw Materials, Customer Materials and/or starting materials consumed in any Failed Drug Substance Batch or Failed Drug Product Batch except to the extent set forth in Clause 7.5.3.

  • Each invoice shall set forth in reasonable detail the amounts payable by HMI under this Agreement and contain the following information, as applicable: Supplier’s name, associated Purchase Order or SOW reference number, HMI contact name, the applicable Drug Substance Batch Price, Filling Price or Service fees, [***] in connection therewith.

  • For clarity, except as expressly excluded by the foregoing paragraph, Lonza is obligated to manufacture each cGMP Drug Substance Batch and each cGMP Drug Product Batch to meet the Specifications.

  • If the dispute remains unresolved, the Parties, acting through their appropriate scientific and technical personnel shall meet to work through the analysis of one or more mutually agreed sample(s) taken from the Drug Substance Batch that is the subject of the dispute.


More Definitions of Drug Substance Batch

Drug Substance Batch means a production batch of a given Drug Substance manufactured in bulk form hereunder. The applicable batch size(s), in kilograms, for each Drug Substance shall be agreed to by the Parties and set forth on the corresponding Drug Substance Appendix.
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Related to Drug Substance Batch

  • 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.

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

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

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

  • 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.

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

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

  • 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.

  • 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;

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

  • Manufacturing Process means any process for—

  • 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.”

  • API means the American Petroleum Institute.

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

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

  • 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.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).