Data Integrity in the Chromatography Laboratory

Principles of Data Integrity in a GLP laboratory

If there is an area of main concern regarding Data Integrity in the chromatography laboratories, this resides in the very first moment of generating and managing raw data. Chromatographic analysis can be easily manipulated when not in accordance with what is expected. Transforming failing results into passing ones, for example, is too often mentioned in FDA warning letters and therefore needs to be controlled to ensure the integrity of the results.

Together with Mr. R.D. McDowall, Mr. Mark Newton, member of the Paperless Lab Academy advisory board, has elaborated 6 exhaustive articles, published in LCGC North America, which cover the principles of handling correctly data integrity from a practical angle. Those principles are key within a regulated good laboratory practice ( GLP) and applicable to any laboratory that is looking for reinforcing quality work and comply also within the ISO17025.

The six articles now completely available are articulated as follow

The scope of this series of six articles is shown in Figure 3 and explained in more detail below

1. Sampling and sample preparation

Two of the most critical areas in an analysis that are mostly manual and could be easily manipulated. read more

2. Setting up a chromatograph and acquiring data

What should be done to ensure the correct set up of an instrument, how to run system suitability test samples and the acquisition of data. read more

3. Integrating and interpreting data

What should be done to control the integration and interpretation of the chromatographic runs? read more

4. Reporting the results

Calculation of the reportable result from an analysis and handling out of specification results and data that have been invalidated in the testing process. read more

5. Second-person review

Reviewing the records to see that work has been carried out correctly, to ensure that the complete record of testing is present, and to determine if any work is incorrect or potentially falsified. read more

6. Culture, training, and metrics

Changing behavior in an organization, training for data integrity, and monitoring analytical work in the laboratory read more

From the Paperless Lab Academy organisation, we´re glad to count on such knowledgeable contributor. Mr´Mark Newton is essential to guide our committee decisions with firm feet on the floor supported by years of experience.

Mark Newton

Principal of Heartland QA, an independent consultant with 30+ years of experience in pharmaceuticals as a laboratory scientist, then as a QA professional, supporting LIMS systems, standalone lab instruments, lab informatics and metrics, validation, quality systems, and data standards. Has been deeply involved in data integrity and data integrity training to people in QC Laboratories, Manufacturing, and IT.

Current Chair of the ISPE Global Documents Committee

Current co-leader of the ISPE/GAMP Data Integrity Special Interest Group

Co-author for “GAMP Guide: Records and Data Integrity”April, 2017

Co-author of “Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification” Schuessler, Newton, Smith, Burgess, McDowall. Pharm. Engineering, Jan/Feb 2014

Co-editor of the GAMP Good Practice Guide “A Risk-Based Approach to Compliant Computerized Laboratory Systems” Nov. 2012.