The Challenges of Ensuring Laboratory Data Integrity

Laboratory data integrity is assuming greater importance in pharmaceutical GMP to assure the quality raw materials, in process materials and finished goods. The reason is simple: if the integrity of laboratory data is compromised or suspected of being compromised, then how can any batch of finished goods comply with the marketing authorisation and be released for sale? Furthermore problems may arise if supporting analytical data are unavailable during an inspection as compliance with the marketing authorisation cannot be demonstrated.

The new version of EU GMP Chapter 4, published in January and effective from 30th June, requires that the raw data for batch release is defined for both homogeneous and hybrid systems. Therefore integrity of laboratory data generated needs to be ensured for:

  • Paper systems (homogeneous)
  • Paper and electronic systems (hybrid)
  • Electronic systems (homogeneous)

The problem is that "raw data" has not been defined in Chapter 4. Therefore the first challenge for ensuring integrity of laboratory data is to define what is meant by the term raw data.  Here the Good Laboratory Practice regulations can be helpful as these regulations (21 CFR 58.3 (k)) define the term as:

Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a non-clinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study.

The key phrase in this definition is "original observations". Interpretation of this phrase can vary depending on the process that you are considering: paper, hybrid system (paper plus electronic records) and fully electronic. 

The second challenge for laboratory data integrity is for hybrid systems: how do you keep paper and electronic records synchronised so that they say the same? The new records retention requirements in EU GMP Chapter 4 state if the records are supporting a marketing authorisation, then the records have to be maintained including the data integrity for as long as the MA is in force.

Computerised systems bring the third challenge for laboratory data integrity: how to use the computer system itself to help ensure data integrity? The recently published EU GMP Annex for computerised systems 11, also effective on 30th June 2011, has several sections dealing with data integrity. One example is the manual entry of critical data; this needs to be checked by a second person or a validated process using the computer itself. How would you interpret this for laboratory data?

To help laboratory and quality assurance personnel ensure the integrity of laboratory data, the ECA course "Laboratory Data Integrity" is available in Vienna, Austria, from 15-16 June 2011. Concentrate on implementing best practices in your laboratories before a regulatory inspection.

Dr R.D.McDowall
Pharmaceutical Consulting Alliance (

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