Data Integrity in Microbial Analysis : Pharmaceutical Guidelines

Data Integrity in Microbial Analysis

A lot of cases of data integrity issues are found in pharmaceutical audits. In microbial analysis it is easy to change or manipulate the data because in most of the cases we can't save the raw data i.e petriplates and test tubes.
Data integrity in microbial analysis refers to the maintaining and assuring the accuracy of the data that is being obtained from the raw information. Microbiological laboratories handle a lot of important data. In most of the occasions, those are the mix of quantitative as well as the qualitative data. Though protecting the pharmaceutical microbial data against vulnerability is much more important. Still, it has not received much attention in terms of regulatory guidance.

However, still, there are lots of people in the pharmaceutical industry itself who are overwhelmed by the concept of data integrity. And that is the main area of concern. Without prior knowledge of the industry people, we could hardly manage to maintain the data integrity in the microbial analysis. To hide test failures or manufacturing deviations often the microbiological laboratories try following unethical stance, which contributes most to the lack of data integrity.
Data Integrity in Microbiology Laboratory

  • Omission of data
  • Errors in the data recording
  • Changing data
  • Deleting data
  • Destroying data

Importance of Data Integrity in Microbial Analysis

The integrity of some microbiological data variates than other which are tested in another laboratory. Sometimes data may get more vulnerable than data loss or than a corrupted data. For an example, a week's study of the environmental changes of a lower grade cleanroom; if gets corrupted then it is less essential than a loss of a single failing sterility test result.

In the cases of data vulnerability, the data stored in the computerized system are more likely to get corrupted if not covered by the conventional procedures, unauthorized changes or by the manipulation. Intended or unintended manipulation of data can be prevented by having a good control over the computerized systems or with an appropriate password access.

What Causes Data Integrity in Microbial Analysis

The regulatory agency FDA has recently issued a letter, in which this data integrity issue has been highlighted. Several causes contribute to this data integrity issue.

  • Colony forming units are miscounted while counting the plates.
  • The sample is displaced like an environmental study sample is not taken or dropped anywhere like in a transit or incubator
  • Finger dabs are not taken properly as a staff member leaves an aseptic processing area.
  • No reconciliation of paperwork and the samples. 
  • Failure to record a cleaning or disinfection session. 
  • A worksheet being ripped up and the results re-written onto a second sheet. 
  • Lack of reconciliation of printed forms. 
  • An issue with the computer systems. 
  • Out-of-limits results not being investigated. 
  • A typical organisms being recorded by microbial identification or the organism not matching the colonial description.
  • Evidence of microbial identifications being re-run in order to obtain a better result.

Key Factors for a Robust Data Integrity System

We need to consider several factors to make a good data integrity system. Firstly, the laboratories need to follow a procedure to analyze all samples tested in the laboratory. Most importantly, the procedures must describe the way to measure the quality and acceptability of the data.

Maintaining the data integrity in the microbial analysis is a must thing and only a high-end security. In the end, data integrity in a pharmaceutical company can only be ensured by the strict maintenance of highly competent and ethical standards.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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