GMP Inspection Checklist & Most frequently asked questions about HPLC

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?

About Abha Maurya

Check Also



error: Content is protected !!