Qualification Batch definition

Qualification Batch or “Qualification Lot” means a Batch or Lot produced from a Qualification Run.
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Qualification Batch has the meaning set forth in the MDSA.
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Qualification Batch means a batch of a Bulk Product SKU or API (as applicable) that meets the Specifications and that is in compliance with applicable Laws that is Manufactured to assess the ability of a party to Manufacture such batch in accordance with the then-current Manufacturing process.
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Examples of Qualification Batch in a sentence

  • Policy #7604 – Acquired Immune Deficiency Syndrome and/or Positive Blood Tests to the Human Immunodeficiency Virus (HIV) Approve New Textbooks – Agenda #5.H.The Board accept the recommendation of the Superintendent and approve the purchase of the following new textbooks for the John G.

  • For each Successful Qualification Batch [*] manufactured by not later than [*]and in compliance with this Agreement and conformance to cGMP, the Bulk Drug Specifications, the Target Yield, and the warranties provided in Section 7.1 hereof, Genentech shall pay Lonza an amount equal to [*] per Batch and, subject to Section 4.5, the Acquisition Cost of raw materials used to manufacture each such Batch.


More Definitions of Qualification Batch

Qualification Batch means a Lot of Active Ingredient that meets Specifications and is manufactured following a work plan and in compliance with cGMPs and Applicable Laws to assess the critical parameters and test the proper functioning of a manufacturing process.
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Qualification Batch or "Qualification Lot" means a Batch or Lot produced
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Related to Qualification Batch

  • Qualification Date means the date as of which the Offering Statement was or will be qualified with the Commission pursuant to Regulation A, the Act and the Rules and Regulations; and

  • Prequalification means the process set out in the Rules for determining whether an applicant is eligible to bid in a capacity auction in respect of a CMU;

  • Qualification Period means the period of time in which a CDC Owner, Operator or a Qualified Colocation Tenant is eligible for Program benefits and means specifically (a) in respect to a CDC Owner or Operator, as defined in subsection IX.A. and (b) in respect to a CDC Qualified Colocation Tenant, as defined in subsection IX.B.

  • Monthly Qualification Cycle means a period beginning one (1) Business Day prior to the first day of the current Statement Cycle through one (1) Business Day prior to the close of the current Statement Cycle.

  • Qualification Deadline has the meaning set forth in Section 2(a)(ii).

  • Qualification Defect With respect to a Mortgage Loan, (a) a defective document in the Mortgage File, (b) the absence of a document in the Mortgage File, or (c) the breach of any representation, warranty or covenant with respect to the Mortgage Loan made by the Company, but, in each case, only if the affected Mortgage Loan would cease to qualify as a “qualified mortgage” for purposes of the REMIC Provisions.

  • Qualification Requirements means the qualification requirements as set forth in Section-2, Clause 2.1 of this RFP;

  • Minimum Qualifications means the requirements of education, training, experience and other basic qualifications for a job.

  • pre-qualification means a screening process designed to ensure that invitations to bid are confined to capable providers;

  • Qualification means any degree, diploma or certificate conferred upon a person after having been examined in respect of that person’s proficiency in a particular field of study;

  • Request for Qualifications means all materials and

  • Qualifications , in relation to an employee, means any degree, diploma or other academic, technical or professional qualification relevant to the position which he held.

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of the Borrower, any qualification or exception to such opinion or certification:

  • Nondisqualification Opinion An Opinion of Counsel, prepared at the Trust’s expense and payable from the Collection Account, that a contemplated action will not cause (i) either the Lower-Tier REMIC or the Upper-Tier REMIC to fail to qualify as a REMIC or (ii) a “prohibited transaction” or “prohibited contributions” tax to be imposed on either the Lower-Tier REMIC or the Upper-Tier REMIC at any time that any Certificates are outstanding.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • Eligibility Requirement means all eligibility requirements and other qualification requirements for a person to act in the applicable Corporate Trust Capacity under any Appointment as set forth in the related Corporate Trust Contract, including any required authorizations or licenses from the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation, the Government National Mortgage Association, the Federal Housing Administration, the Federal Home Loan Bank or the Department of Veterans Affairs.

  • Statewide special election means a special election called by the governor or the

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Statewide popular election means a general election in which votes are cast for

  • Local special election means a special election called by the governing body of a

  • Eligibility Requirements means, with respect to any Person, that such Person has at least $200,000,000 in capital/statutory surplus or shareholders’ equity (except with respect to a pension advisory firm or similar fiduciary) and at least $600,000,000 in total assets (in name or under management), and is regularly engaged in the business of making or owning commercial real estate loans (or interests therein), mezzanine loans (or interests therein) or commercial loans (or interests therein) similar to the Mortgage Loan.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Disqualification means the Athlete’s results in a particular Competition or Event are invalidated, with all resulting Consequences including forfeiture of any medals, points and prizes;

  • TLAC Disqualification Event means OSFI has advised the Bank in writing that the bail-inable notes issued under the applicable pricing supplement will no longer be recognized in full as TLAC under the TLAC Guideline as interpreted by the Superintendent, provided that a TLAC Disqualification Event will not occur where the exclusion of those bail-inable notes from the Bank’s TLAC requirements is due to the remaining maturity of those bail-inable notes being less than any period prescribed by any relevant eligibility criteria applicable as of the issue date of those bail-inable notes.

  • District specification means the specifications followed by the State Govt. in the area where the work is to be executed.