35. Performance Qualification (PQ) Package

35. Performance Qualification (PQ) Package

Regulators agree that you can outsource services, but they insist that you cannot outsource your GXP responsibility. (p. 160)   The figure below illustrates the PQ variation on the Standard Package Model     Every Performance Qualification (PQ) validation package needs to have a Service Level Agreement (SLA) to define the roles, responsibilities and reparations…

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