QSR Standard definition

QSR Standard means the regulations set forth in 21 CFR Chapter 1, Part 820, et seq., as such regulations may be amended or replaced from time to time, and any foreign law, statute or regulation relating to current good manufacturing practices.
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Examples of QSR Standard in a sentence

  • Within ninety (90) days after the Effective Date, quality/regulatory representatives from both Parties will meet to define and document processes for exchange of customer complaints, trends or other information concerning Alliance Products necessary to be shared between the Parties to ensure compliance with the Quality System Regulation provisions of the applicable Regulatory Authorities or other international agencies for conformity to QSR Standard, ISO and other applicable regulatory requirements.

  • Each Party will perform its obligations under the Alliance Program (whether itself, or with or through a contractor, agent or sublicensee) in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws, regulations, current good laboratory practices and the QSR Standard.

  • Not For Use In Diagnostic Procedures” or any comparable label subsequently required by applicable Regulatory Authority, (ii) are not claimed by the Party that they were manufactured under the QSR Standard, except that they may be claimed to have been manufactured under a certified quality system with traceable documentation, and (iii) are not Commercialized by the Party in a manner that Facilitates use as a Competing Product.