System calibration program

After initial qualification, the system is placed in service and is kept in a qualified state using a periodic calibration program. In addition, its performance for the specific application is also verified at the time of use using system suitability testing. This section describes the procedures and documentation used for HPLC hardware qualification. Detailed discussions of this subject can be found in books and articles elsewhere.3,4 The regulations and qualification of computerized data systems and networks with their associated software can be quite elaborate and is described elsewhere.5 7... 

System calibration refers to the periodic operational qualification of the HPLC, typically every 6 to 12 months in most regulated laboratories. This calibration procedure is usually coordinated with an annual preventative maintenance (PM) program and is performed immediately after PM. A calibration sticker is placed on the instrument to indicate its calibration status and readiness for GMP work. The reader is referred to the principles and strategies behind HPLC calibration criteria published elsewhere.8 A summary of the calibration procedures and acceptance criteria, including additional procedures recommended for initial operational qualification, is listed in Table 9.3. 

The system is installed in accordance with design specifications, manufacturer recommendations, and cGMPs. Instruments are calibrated, identified, and entered into the calibration program. 

---