Root Cause Analysis of the Data Integrity Issues

  • Calendar December 21, 2018

This is the challenge industry is facing currently.

Jalpan is the young enthusiast and great professional. He looks for industry challenges and possible solutions.

Jalpan Upadhyay - Sr. Executive, Business Development

Since last few years main focus of regulatory audits especially in India, is on the Data Integrity Issues. The correctness and truthfulness of the data generated in Pharmaceutical Industry was never scrutinized so much in detail. The falsification of the data by various organizations is the main concern of the various regulatory agencies. However, there is insufficient brainstorming on the Root Cause Analysis of this problem.


It is also surprising that there are hundreds of seminars and lectures being arranged to discuss the Data Integrity issues with assumption that the pharmaceutical professionals right from ‘officers’ to ‘managers’ do not know that the Data generated in Pharmaceutical organization has to be truthful. It is so ridiculous that tremendous efforts are being taken and lots of funds being wasted to tell ‘officers’ to ‘managers’ what they already know; whereas very little focus is on eliminating the Root Causes of the catastrophe.


In fact no ‘officers’ and ‘managers’ will on their own deviate from the procedures or falsify the data unless they are forced to accommodate the poorly developed processes i.e. without QbD (Quality by Design), as well to accommodate the inadequate resources and infrastructure provided by management. This is applicable for all the departments and functions in the organization.


Need of the time is to develop complacent GMP atmosphere in the industry, which will allow ‘officers’ and ‘managers’ to remain truthful, which they actually want to. It is utmost important to provide them all the resources including time to meet regulatory requirements and expectations. Unfortunately the guidelines like ICH Q8 (QbD), ICH Q9 (Risk Management) and ICH Q10 (QMS) are just remaining on paper. It is so obvious that most of the Data Integrity issues are due to poor understanding and implementation of these basic concepts. It is not surprising that so many batches fail to meet the desired specifications as they are not developed as per QbD. There is invariably insufficient design space provided to make the manufacturing procedure robust. How many organizations are really looking at this important aspect seriously even today? This casual approach and negligence eventually leads to Data Integrity issues as we know.

In my opinion, the efforts taken today are going to be futile as the Root Cause is not being addressed the way it should be. This is my sincere effort to create awareness in the minds of Top Management of the organizations as well as authorities to ensure improvement in true sense. It should be well understood that Quality Metrics is a tool useful for authorities to monitor compliance level organizations. It is neither a direct solution for addressing Non Compliance and Data Integrity issues nor it is replacing QbD anyways.

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