Design qualification for HPLC 🤔

Design qualification (DQ) describes the user requirements and defines the functional
and operational specifications of the instrument. It should ensure that instruments to be purchased have the necessary functions and performance that will enable them be suitable for the intended applications.

Design elements :

1) Intended use : Analysis of drug compounds and impurities. 

2) User requirement specification for

the HPLC analysis : 

- Up to 100 samples / day. 

- Automated over-night analysis. 

- Limit of quantitation: 0.1%. 

- Automated confirmation of peak identity

and purity with diode-array detection. 

- Automated compound quantitation and

printing of report. 

3) Functional specifications :

- Pump : Binary or higher gradient. 

- Detector : UV/Vis Diode-array, 190-900 nm. 

- Autosampler : 100 samples, 0.5 ul to 5 ml sample volume. 

- Column compartment : 15 to 60 Deg C, peltier controlled. 

- Computer : System control, data acquisition for signals . 

and spectra, peak integration and quantitation, spectral evaluation for peak purity and compound confirmation. 

Electronically save all chromatograms

generated by the system.

4) Operational specifications :

- Detector: Baseline noise: <5 x 10-5 AU. 

- Sampler: Precision inj. volume: <0.5%

RSD. 

- Pump: precision of retent.time: <0.5%

RSD. 

5) User instructions :

- Operational manual on paper. 

- Computer based tutorial. 

6) Validation/qualification :

Vendor must provide procedures and services for IQ and OQ. 

7) Maintenance :

- Vendor must deliver maintenance procedure and recommend schedule. 

- Maintenance procedures must be supplied

on Multimedia CD ROM. 

8) Training :

Vendor must provide familiarization and

training.