PPQ Runs definition

PPQ Runs means the Process performance qualification Batches of BDS and Drug Product, separately that will be used as basis for the Process Validation for regulatory process validation and qualification of BDS manufacturing and Drug Product manufacturing hereunder. Such PPQ Runs shall be completed under the terms of the CSA, for Drug Substance and Drug Product.
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PPQ Runs means the Manufacturing Process performance qualification Batches which will be used as basis for the Process Validation.
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Examples of PPQ Runs in a sentence

  • As the Purchase Prices for Drug Product for [*] PFS filling [*] in Appendix 3 are based on Manufacturing Assumptions, such prices for Drug Product for [*] PFS filling [*] may need to be revised after the performance of the PPQ Runs for Drug Substance currently scheduled for [*] and Drug Product currently scheduled for [*] (covered under the CSA) as set forth in Section 3.1.

  • The Parties understand that commercial Product supply obligations hereunder are dependent on successful completion of the PPQ Runs for Drug Substance and/or Drug Product under the CSA to establish the Manufacturing Process.

  • Versartis wishes to have BI perform additional Drug Substance Services including but not limited to development and optimization and manufacture of additional Phase III Drug Substance and performance of PPQ Runs for the validation of Drug Substance at the Facility.