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Calibration | As per EU and USFDA GMP Requirements

The pharmaceutical sector is governed by regulatory norms to ensure that quality standards are met for products in line with pharmaceutical cGMP guidelines. The aim of the calibration procedure is to establish the accuracy of the equipment being used. This helps to control for errors and uncertainties, ensuring that the data collected is reliable and accurate.

Pharmaceutical instruments are essential tools used in the development, manufacturing, and testing of pharmaceutical products. They are relied upon to provide accurate measurements and results, which is crucial for ensuring the safety and efficacy of pharmaceutical products. However, over time, the accuracy of these instruments can drift, leading to potential errors and incorrect results. This is where calibration comes in, and it is a critical component of pharmaceutical quality control.

Calibration is the process of adjusting and verifying the accuracy of a measuring instrument. It involves comparing the readings of an instrument to a known reference standard and making any necessary adjustments to bring the readings into alignment. The purpose of calibration is to ensure that an instrument is providing accurate and consistent measurements, which is essential for maintaining the quality of pharmaceutical products.

There are several reasons why calibration is important for pharmaceutical instruments.

  • First and foremost, calibration helps to ensure that the instruments are providing accurate measurements. If an instrument is not calibrated correctly, it can produce incorrect results, leading to potential safety issues or compromised product quality. Calibration helps to prevent these issues by verifying that the instrument is functioning properly.
  • Secondly, calibration is required by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Related: Analytical Instrument Qualification

The requirements as per both EU and USFDA GMP are as below:

Calibration is a key component of these regulations and is necessary for demonstrating compliance.

EU GMP (Chapter 3.41)

“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”

USFDA GMP (21 CFR 211.68)

“Equipment … shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.”

Regular calibration can help to identify issues with an instrument early on, allowing for prompt repairs or adjustments to be made.

So the calibration is a critical component of pharmaceutical quality control. It helps to ensure the accuracy and consistency of pharmaceutical instruments, which is essential for maintaining the safety and efficacy of pharmaceutical products.

Read also: Equipment Qualification and Mapping in Labs

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