01.10.2019 | LOGFILE Feature 36/2019

An excerpt from the GMP Compliance Adviser, Chapter 14.L.1 and the GMP Focus e-book Data Integrity in the EU

Data integrity in the quality control laboratory

Data integrity in the quality control laboratory

5 min. reading time | by Markus Veit


This chapter deals with the practical aspects of implementing the European requirements for data integrity. A HPLC laboratory for pharmaceutical quality control is used as an example in which data for the batch release of a finished medicinal product is generated. A schematic representation of the underlying process is shown in Figure 1.

Figure 1: Quality control and batch release

What types of data (in accordance with the WHO guidance, see 15.H Data integrity – general requirements in a GxP-regulated environment and H.17 WHO: Guidance on good data and record management practices (Technical Report Series, No. 996 (2016), Annex 5)) are collected in a chromatography laboratory? The most important types are listed below:

  • data from the tested batch and data on personnel who carry out and control the testing process
  • sampling and sample storage data, records and observations
  • weighing and sample preparation, standards and reagents used
  • qualification and calibration data for the pipettes and balances used
  • qualification dara for all of the devices used
  • instrument control data (detector wavelength range, flow, temperature, etc.)
  • sequence data in full
  • data to be recorded (e. g. data rate, integration parameters, etc.)
  • chromatography testing data (initial electronic data, peak areas)
  • processed data from chromatography testing (processed electronic data)
  • measuring process and device-specific calibrations
  • device-specific calculations
  • peak areas after integration
  • HPLC calibration data
  • calculation data (software-based or completed manually)
  • trend analyses
  • all system suitability test results
  • reports generated from electronic data (sample-list printouts, chromatograms, etc.)
  • audit trail data and all deviations and changes
  • documented observations
  • if applicable, calculations carried out using external software (LIMS, Excel) = derived data, results (reportable result), evaluation (with OOS, OOE, OOT)

This text is an excerpt from the GMP Compliance Adviser, Chapter 14.L.1 and the GMP Focus e-book Data Integrity in the EU

Markus Veit


Markus Veit, Professor PhD
Managing Director of ALPHATOPICS GmbH
E-Mail: m.veit@alphatopics.de
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