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IPCs Vs concurrent PV

Discussion in 'Qualification & Validation (Also 21 CFR Part 11)' started by leomac83, Sep 12, 2021.

  1. leomac83

    leomac83 Member

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    As the title suggests, when or what must be considered to understand if one or more IPCs can replace a concurrent PV, after a change/project for example?

    PV = Process Validation = GMP Annex 15: The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

    IPC = In-process control tests are the most widely used tests/criteria to monitor the progress of the manufacturing of active pharmaceutical ingredients (APIs) and intermediates.