GMP Standards definition

GMP Standards means the good manufacturing practice standards, designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product;
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GMP Standards means the Colombian good manufacturing standards for pharmaceutical laboratories in accordance with the guidelines set out in Decree 549 of 2001 and INVIMA Resolution 01087 of 2001;
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GMP Standards means the Good Manufacturing Practice regulations determined by the U.S Food and Drugs Association as shall be updated from time to time and applied by the Supervisor of GMP.
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Examples of GMP Standards in a sentence

  • Centogene shall ensure through its Third Party subcontractor at its own expense, that the Facility and all equipment required for the manufacture of Contract DBS Test Kits are in a state of repair and operating efficiency consistent with the requirements of GMP, Standards and Applicable Laws.

  • The Active Pharmaceutical Ingredients (API) used in the vitamin A soft gelatin capsules must be manufactured and handled according to GMP Standards for Pharmaceutical Products, as certified by an internationally recognized authority that is a member of or partner to the Pharmaceutical Inspection Cooperation Scheme (PIC/S)7.

  • DepoMed shall maintain records, in sufficient detail and in compliance with GMP Standards and generally accepted accounting principles, and for a period of three (3) years after the completion of the Work Plan, which records shall fully and properly reflect all work done, and all results achieved by DepoMed in the performance of its obligations under this Agreement.

  • DepoMed shall use commercially reasonable efforts to ensure that any facilities at which all or part of the Development of the 500 mg strength of the Licensed Product is conducted complies with all required GMP Standards.

  • The Product used in the Study shall be processed in a class 10,000 laboratory in Hadassah National Facility operated according to GMP Standards under the Agreement attached hereto as Schedule B.

  • All Acquired Inventory has been stored in accordance with GMP Standards.

  • Australian authorities have stated that products produced in countries where medical Cannabis is legal can be prescribed and trialed in Australia as long as the products in question have been produced to GMP Standards.


More Definitions of GMP Standards

GMP Standards shall have the meaning accorded to it in Paragraph 3.2 hereof.
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GMP Standards means the FDA’s standards for good manufacturing practices set forth at 21 CRF Parts 210 and 211.
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