04 Qualification And Validation Overview

GMP Requirements

Qualification, Calibration and Validation: Qualification: Equipment and systems (HVAC, Water, etc.) Calibration: Should cover the working range Process validation: Evidence of consistency–data integrity Product Recalls Effectiveness of recall procedures assessed and regularly evaluated – mock recall

  Requirements, Qualification, Validation, And validation, Gmp requirements

Automotive SPICE

2.0 2005-05-04 AutoSIG / SUG DRAFT RELEASE, pending final editorial review 2.1 2005-06-24 AutoSIG / SUG Editorial review comments implemented Updated to reflect changes in FDIS 15504-5 2.2 2005-08-21 AutoSIG / SUG Final checks implemented: FORMAL RELEASE 2.3 2007-05-05 AutoSIG / SUG Revision following CCB: FORMAL RELEASE

Automotive SPICE

2.0 2005-05-04 AutoSIG / SUG DRAFT RELEASE, pending final editorial review 2.1 2005-06-24 AutoSIG / SUG Editorial review comments implemented Updated to reflect changes in FDIS 15504-5 2.2 2005-08-21 AutoSIG / SUG Final checks implemented: FORMAL RELEASE 2.3 2007-05-05 AutoSIG / SUG Revision following CCB: FORMAL RELEASE