U.S. GMP's definition

U.S. GMP's means the good manufacturing practices / quality systems regulations for manufacturing medical devices (21USC820 et seq., as amended from time to time) and other applicable laws, regulations and restrictions of those governmental or regulatory agencies within the U.S. responsible for regulating the manufacture, sale and distribution of medical devices.
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Examples of U.S. GMP's in a sentence

  • Carbylan hereby confirms that all quantities of the Compound delivered to Jingfeng pursuant to this Section 3.2 shall be manufactured in compliance with U.S. GMPs, and the quality of such Compound shall be certified by Carbylan’s quality control (QC) department.

  • The parties shall agree, in writing, prior to initiating a Recall, regarding the manner, text and timing of any publicity to be given such matters in time to comply with all Applicable Laws and the U.S. GMP's, but such agreement shall not be a precondition to any action that either party deems necessary to protect users of the Products or to comply with any applicable governmental orders.

  • Distributor shall comply with the Applicable Laws, and ---------- Company shall comply with the U.S. GMP's.

  • Company and Distributor agree to enter into and to comply with the terms of a Supplier Quality Agreement, the terms of which shall be consistent with the U.S. GMP's and the Applicable Laws.

  • Company and Distributor will agree on appropriate Product complaint reporting procedures and ensure that these are in place for the reporting of adverse events directly to the appropriate regulatory authorities as required by the Applicable Laws and the U.S. GMP's.