GMP Inspection Checklist & Most frequently asked questions about HPLC
HPLC is an abbreviation for High-Performance Liquid Chromatography. “Chromatography” is a technique for separation, “chromatogram” is the result of chromatography, and “chromatograph” is the instrument used to conduct chromatography. HPLC dedicated to molecular separation called columns and high-performance pumps for delivering solvent at a stable flow rate are some of the key components of chromatographs. Only compounds dissolved in solvents can be analyzed with HPLC. HPLC separates compounds dissolved in a liquid sample and allows qualitative and quantitative analysis of what components and how much of each component is contained in the sample.
- Do you have policies and procedures that specify how the staff is given access to HPLC systems?
- Are individual login and passwords required to access HPLC systems?
- Does your software control actions through access privilege levels?
- Are the date and time featured secured so they cannot be changed by those who perform, supervise, or review records?
- Is the identity of the person performing an activity captured by the audit trail?
- Are your audit trails capable of documenting why an action was performed?
- Is the data being reviewed in the same format in which it was generated?
- Is the mobile phase prepared as per STP?
- Is the mobile phase valid for a recommended date?
- Check the calibration status of the instrument
- Is the column available as per standard testing procedure?
- Is the entry of the column in the logbook maintained?
- Is the right method selected by the user?
- Is the sequence of the sample set as per STP?
- Is the flow rate of the method as per STP?
- Is the sample prepared as per STP?
- Is the system suitability pass as per STP?
- Are no fluctuations in column pressure?
- Is no leakage observed in the system?
- Are all peaks integrated properly?
- is the RSD of the area within the limit?
- Is bracketing of injection within the limit?
