Tuesday , September 26 2023

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

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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