Lack of Data Integrity in Pharma

It’s often deviant discrepancies, poor procedures or deficient data that can cause a pharma company to commit lapses of varying levels. In a rarity, when there’s corrupt culture, then there are chances that possible data integrity violations, during internal audit processes, will remain unreported and off the record.

Counting the inspection date, speeding up everything for assessments and preparations, masking incomplete data records, pleasing the inspectors with warm welcome, and after the inspection back to normal, with inconsistent procedures doesn’t make good business sense.

Worst scenarios, in some pharma companies, are when production line workers, who carry out their assigned functions, with little instructions and without any compliance concerns, structured training and sufficient experience.

How can a pharma company be GMP compliant when it lacks data integrity?

It’s ridiculous to ensure product quality when a company lacks accurate production batch records, data results, lab test information or maintenance logbooks. With no controlled processes, appropriate documentation and traceability, there can be no trustworthiness.

In a large pharma company, when there are sagging systems and postponed procedures, then there’s every possibility of quality deviations, compliance issues, data manipulation and risk scenarios.

For instance, from product development to product launch, when all the relevant departments work in silos, with systems incorrectly configured and teams in discord, then there will be neither effective and timely regulatory compliance nor efficient and measurable outcomes. Ugh...when nothing works well, there’s all troubling pain, waste of money and time.

Lack of data integrity simply means that a total manufacturing plant or concerned departments are messed up.

Probably, deviations and gross errors occur when activities are done in a haphazard or unrealistic manner.

Based on your own preferences, you cannot select an unqualified vendor by falsifying records or bypass vendor qualifications under pressure or for some favouritism. That’s totally erratic!

Sometimes ignoring simple coordination, incomplete, wrong or altered information and pivotal follow ups to deal issues delays the regulatory submissions, and subsequently hampering the whole project with too many gaps.

And sometimes following wrong parameters can weaken the products brand value. In one company, for more than a decade, the stability studies section conducted stability studies, without proper protocols and calculations, for shelf life estimation. And the serious errors came into the limelight when the company, at one time, faced customer complaints related to quality.

Image source: pharmamanufacturing.com