Calibration of Analytical Instruments as Per ICH and USFDA Guidelines

Authors

  • Vemuluri Padmabhushana Chary Department of Pharmaceutical Analysis, Anurag Pharmacy College, Kodad-508206, Telangana, India.
  • D. Sireesha Department of Pharmaceutical Analysis, School of Pharmacy, Anurag University, Hyderabad-500088, Telangana, India.

DOI:

https://doi.org/10.9734/bpi/strufp/v12/2062

Keywords:

Calibration, spectrophotometer, analytical instruments, regulatory approval

Abstract

Calibration of analytical instruments in accordance with ICH and USFDA requirements is vital for ensuring the quality, reliability, and accuracy of analytical data. Calibration of analytical instruments such as UV-visible spectrophotometer, FTIR, HPLC, GC, Fluorimeter and Flame photometer was discussed. The focus was on practical methods to ensure accurate and reliable measurements in analytical chemistry, which is critical for maintaining quality control and meeting regulatory standards in laboratory analyses [1,2]. The guidelines provide a framework for validating the performance of instruments, including specifications for calibration frequency, acceptable limits, and documentation.

Published

2024-09-19

How to Cite

Vemuluri Padmabhushana Chary, & D. Sireesha. (2024). Calibration of Analytical Instruments as Per ICH and USFDA Guidelines. Science and Technology: Recent Updates and Future Prospects Vol. 12, 133–148. https://doi.org/10.9734/bpi/strufp/v12/2062