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GMP LOGFILE Features

2018-10-04

LOGFILE No. 36/2018 – Calibration of Laboratory Instruments

Calibration of Laboratory Instruments

An excerpt from the new GMP Series PDF Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction

5 minutes reading time

by Josef Künzle, PhD

 

Change analysis (CA)

The calibration of analytical instruments is stipulated in the GMP Guidelines. During calibration, it is checked whether the qualified status of the instrument has been preserved. Non-calibrated analytical instruments may not be used for testing.

In accordance with the EU GMP Guidelines, Part I, calibration is defined as follows (cf. Figure 1):

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Figure 1 Definition of calibration in accordance with the EU GMP Guidelines, Part I, Glossary (C.7 Glossary)

It is important to differentiate between calibration, and adjustment and gauging; they are defined as follows:

  • DIN 1319 defines adjustment as follows: "Adjustment is the setting or balancing of a measuring instrument to eliminate systematic measurement deviations to the necessary extent or as far as possible. Adjustment therefore requires an action which permanently alters the instrument."
  • Gauging is the mandatory testing of measurement instruments for compliance with the underlying legal calibration regulations, especially the calibration error limits. A stamp confirms the expected compliance for the period of validity of gauging. Or in other words: gauging is a legally required calibration that can be traced back to national standards (Wikipedia).

Calibration programme

The calibration programme is used to ensure that all instruments are calibrated at regular intervals. The calibration programme can be described in an SOP that is the "higher-level" calibration SOP.

The general requirements that apply to all instruments are listed in Figure 2.

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Figure 2 Contents of the calibration programme

The guidelines contain no mandatory requirements with regard to calibration intervals, the question of whether calibration should be carried out on a particular day or month, the scope of calibration or the definition of acceptance criteria. These must be defined internally based on experience. For this reason, the following examples are only suggestions.

Calibration intervals

The calibration intervals can be defined according to the priority of the instruments in the laboratory. Instruments with higher priority are calibrated at shorter intervals than those with lower priority. This approach is illustrated in the example in Figure 3.

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Figure 3           Calibration intervals for laboratory instruments based on priority (example)

It is also possible and, in many situations, imperative to carry out the calibration before use, e.g. in the case of osmometers. This approach also makes sense in the case of instruments that are rarely used.

Because relatively short calibration intervals of 3 months and less are common in laboratories, it is recommended that calibration be scheduled for a particular day. The exact calibration interval is then calculated based on that date (example in Figure 4).

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Figure 4 Setting the due date for calibration scheduled for a particular day

Scope of calibration

There are no mandatory requirements with regard to the scope of calibration. Requirements from the pharmacopoeias or widely recognised requirements can be used as a reference point. For example, a balance must be calibrated over the operating range that is used. A photometer used during GMP analyses should meet the requirements of Ph. Eur. 2.2.25. Critical parameters or other lessons learnt during the qualification of the instrument can also be included in the scope of calibration.

Acceptance criteria

The definition of acceptance criteria can be based on general requirements, e.g. from pharmacopoeias, or on the practical application of the instrument. For example, Chapter 2.2.25 of the European Pharmacopoeia contains requirements affecting photometers. On the other hand, a broad acceptance criterion of ±10% can be perfectly acceptable for a 10-µl piston-operated pipette that is used exclusively for pipetting enzymes during enzymatic determination when a fluctuating amount of enzyme does not affect the result.

LOGFILE-36-Qualification-Calibration-Laboratory-Instruments.pdf

Author:

Josef Künzle, PhD
Chemist
Basilea Pharmaceutica International Ltd, Basel

 


This text is an excerpt from the GMP Series Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction

 

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Qualification of equipment is a basic GMP requirement. This also applies to laboratory equipment. Remember: Qualification begins as soon as a decision has been made to purchase an instrument – and not when a particular instrument has been chosen, procured or even installed!

In contrast to the validation of analytical methods there are no specific directives or methods that apply to the qualification of analytical instruments. This means that a number of different approaches can be taken. But which one should you take?

The pdf download Qualification and Calibration of Laboratory Instruments in Pharmaproduction leads you safely through all steps of qualification and calibration.

The report answers the following questions:

  • What instruments have to be qualified?
  • How is the qualification carried out?
  • What qualification documentation has to be created?
  • What scope of qualification is both useful and necessary?
  • How is instrument software validated?
  • What has to be done when the configuration of an instrument is changed?
  • How are instruments managed?
  • Which instruments have to be calibrated?
  • How and how often is calibration carried out?
  • What needs to be done if calibration is not successful?
  • How is calibration documented?
  • What level of maintenance is required for laboratory instruments?

A form for a requalification report, samples qualification plan and qualification report and a sample calibration SOP are included as bonus materials.

Order now your copy of Qualification and Calibration of Laboratory Instruments in Pharmaproduction and master all phases of qualification and calibration!

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