GxP Audit definition

GxP Audit means an audit, which is comprised of an evaluation of the state of compliance of the systems and sub-systems, applicable to a manufacturing site, non-manufacturing site, investigator site or service provider site or a GxP system or process, with EU and U.S. standards and ICH Guidelines, and the applicable regulations in the countries where a Licensed Compound or Licensed Product or any component thereof is Manufactured or Commercialized.
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Examples of GxP Audit in a sentence

  • If a Regulatory Authority desires to conduct an inspection or GxP Audit of Legend, its Affiliates, [***] relating to [***], Legend shall [***] notify Novartis upon Legend becoming aware thereof.

  • On and after the License Effective Date, BeiGene will, and will use Commercially Reasonable Efforts to procure that its Third Party Contractors will, use Commercially Reasonable Efforts to agree to remedy any CAPAs identified in any GxP report within […***…] of issue of the GxP Audit report and thereafter carry out required CAPAs within the relevant timelines.

  • If a Regulatory Authority desires to conduct an inspection or GxP Audit of Arvinas, its Affiliates, or its or their subcontractors (including CMOs) relating to the Licensed Products or Licensed Technology, Arvinas shall promptly ([**]) notify Novartis thereof.

  • If a Regulatory Authority desires to conduct an inspection or GxP Audit of PTC, its Affiliates, or its or their subcontractors (including CMOs) relating to the Licensed Compounds or Licensed Products, PTC shall promptly (no later than [***] notify Licensee thereof.

  • If a Regulatory Authority desires to conduct an inspection or GxP Audit of Licensor, its Affiliates, or its or their subcontractors (including CMOs) relating to the Licensed Compounds, Licensed Products or Licensed Technology, then Licensor shall [***] notify Novartis thereof.