GMP Grade definition

GMP Grade means production of a Product in accordance with the Regulatory Standards and the process and procedures described in the Manufacturing Information.
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GMP Grade means Product that has been produced in accordance with applicable Good Manufacturing Practices with respect to active pharmaceutical ingredients.
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GMP Grade means Copolymer that has been produced in accordance with Good Manufacturing Practice regulations as defined by the FDA. 2 "Manufacturing Facility" means the manufacturing facility of CytRx, or any manufacturing facility of a third party licensed and engaged by CytRx to supply the Copolymer in accordance with Section 2.1.
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Examples of GMP Grade in a sentence

  • Trade name: Neutral Protease NB GMP Grade from Clostridium histolyticum (Contd.

  • In such event, Cephalon will use commercially reasonable efforts, including the making of capital investments, to scale-up and expand its manufacturing facility in Beltsville, Maryland to provide GMP Grade IGF-1 for such purpose.

  • Facile & Scalable Synthesis of Plant-Based Cholesterol (BotaniChol®) in GMP Grade [cited 2021 Aug 15].

  • In some senses, the current crisis also represents a major opportunity for “creative destruction”.

  • Results of settle plates, contact plates and active air sampling varied from equivalent EU GMP Grade B to EU GMP unclassified.

  • Line 9: MATLOOB = Derived from TALAB, e.g., to desire Line 9: LA MAKAA(N) = Literal meaning is “the place of no place”.

  • During Phase II, SYNCO warrants that the Batches of rhPTH will be GMP Grade and SYNCO assumes all other obligations in respect thereto, including guaranteeing an average Yield per Batch of the manufacturing process (as established according to Article 4.4), as calculated over thirty (30) Batches manufactured during Phase II which are released by NPS in accordance with Article 6.6.

  • Neose shall supply reasonable quantities of GMP Grade chemicals and enzymes covered by the Neose Technology, solely for GMP manufacturing of the Development Product in accordance with this Agreement, at the sole cost and expense of Neose.

  • Human adipocytes were isolated by treat- ing the adipose tissue biopsies with Collagenase NB 6 GMP Grade from Clostridium histolyticu m(Serva Electrophoresis, Heidelberg, Germany), as described in the manufacturer’s protocol [35].

  • However, formation of explosive dust-/air mixtures are possible.Trade name: Neutral Protease NB GMP Grade from Clostridium histolyticum · Explosion limits: Lower:Upper: Not determined.


More Definitions of GMP Grade

GMP Grade means Copolymer that has been produced in accordance with Good Manufacturing Practice regulations as defined by the FDA. -------------------- The "[X]" marks in Exhibit 10.4 represents deleted material which is subject to a request for Confidential Treatment and has been filed separately with the Secretary of the Securities and Exchange Commission.
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GMP Grade means rhPTH that has been produced in accordance with the Regulatory Standards and the Specifications.
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Related to GMP Grade

  • Pay grade means the monthly salary applicable to class titles of service personnel;

  • Highest Rating Category means, with respect to a Permitted Investment, that the Permitted Investment is rated by S&P or Moody’s in the highest rating category given by that rating agency for that general category of security. By way of example, the Highest Rating Category for tax exempt municipal debt established by S&P is “A 1+” for debt with a term of one year or less and “AAA” for a term greater than one year, with corresponding ratings by Moody’s of “MIG 1” (for fixed rate) or “VMIG 1” (for variable rate) for three months or less and “Aaa” for greater than three months. If at any time (i) both S&P and Moody’s rate a Permitted Investment and (ii) one of those ratings is below the Highest Rating Category, then such Permitted Investment will, nevertheless, be deemed to be rated in the Highest Rating Category if the lower rating is no more than one rating category below the highest rating category of that rating agency. For example, a Permitted Investment rated “AAA” by S&P and “Aa3” by Moody’s is rated in the Highest Rating Category. If, however, the lower rating is more than one full rating category below the Highest Rating Category of that Rating Agency, then the Permitted Investment will be deemed to be rated below the Highest Rating Category. For example, a Permitted Investment rated “AAA” by S&P and “A1” by Moody’s is not rated in the Highest Rating Category.

  • Investment Grade means a rating of Baa3 or better by Moody’s (or its equivalent under any successor rating categories of Moody’s); a rating of BBB- or better by S&P (or its equivalent under any successor rating categories of S&P); and the equivalent investment grade credit rating from any additional Rating Agency or Rating Agencies selected by the Company.

  • Rating Category means one of the generic rating categories of any Rating Agency without regard to any refinement or gradation of such rating by a numerical modifier or otherwise.

  • Threshold Rating means the short-term unsecured debt rating of P-1 by Moody's and A-1 by Standard & Poor's.

  • 2 Wire Analog Voice Grade Loop or “Analog 2W” provides an effective 2-wire channel with 2-wire interfaces at each end that is suitable for the transport of analog Voice Grade (nominal 300 to 3000 Hz) signals and loop-start signaling. This Loop type is more fully described in Verizon Technical Reference (TR)-72565, as revised from time-to-time. If “Customer-Specified Signaling” is requested, the Loop will operate with one of the following signaling types that may be specified when the Loop is ordered: loop-start, ground-start, loop- reverse-battery, and no signaling. Customer specified signaling is more fully described in Verizon TR-72570, as revised from time-to- time. Verizon will not build new facilities.

  • Nameplate Capacity Rating means the maximum capacity of the Facility as stated by the manufacturer, expressed in kW, which shall not exceed 10,000 kW.

  • Investment Grade Credit Rating means (i) a Credit Rating of Baa3 or higher given by Xxxxx’x, (ii) a Credit Rating of BBB- or higher given by S&P or (iii) a Credit Rating of BBB- or higher given by Fitch.

  • Xxxxx’x Rating means, at any time, the rating issued by Xxxxx’x and then in effect with respect to the Borrower’s senior unsecured long-term debt securities without third-party credit enhancement.

  • Gross vehicle weight rating means the weight specified by the manufacturer as the loaded weight of a single vehicle.

  • Rating Point means the V&H coordinates associated with a particular telephone number for rating purposes.

  • Mxxxx’x Rating means, with respect to a Reference Obligation, as of any date of determination:

  • Moody’s Industry Classification means the industry classifications set forth in Schedule 2 hereto, as such industry classifications shall be updated at the option of the Facility Agent in its sole discretion if Moody’s publishes revised industry classifications.

  • Grade means the average level of finished ground adjoining a building or structure at all exterior walls;

  • S&P Rating means, at any time, the rating issued by S&P and then in effect with respect to the Borrower’s senior unsecured long-term debt securities without third-party credit enhancement.