Data integrity, difference in regulatory standards and more — Takeaways from BioAsia compliance panel

Data integrity is not an India issue. However, regulators continue to find data integrity issues which some times is not only about falsifying data, but can be about not reporting data accurately. Hence, data integrity can be linked to basic issues such as incomplete records to forging of signatures. Data integrity in a plant points to the lack of a strong internal audit programme.

The US drug regulator pointed that they find data integrity not only across pharma products, but across other commodities such as food and clinical trials that they oversee in the country. They said one of the reasons for the same is due to the lack of understanding of procedures by people who are executing tasks. At times there is a lack of culture to accept or make mistakes which results in falsifying or hiding data.

Regulators point out that there has to be more empowerment given to people doing tasks. With an environment of feedback, free flowing dialogue within companies critical information is exchanged. Also, changing the duality of the mindset when it comes to manufacturing for India and for developed countries like the US.

Quite a few times a plant is cleared by the USFDA, but isn’t by say the UK's Medicines and Healthcare products Regulatory Agency (UKMHRA). Regulators point to the fact that there are differing compliance standards between other regulators as well.

One way to tackle this is, a push towards harmonisation of global quality standards by following global regulations such as PICS and ICH. However, while following the standards is positive, enforcement of the same might differ between regulators. This means there could continue being multiple inspections by regulators of a single plant.

Lastly, a few broad takeaways were that there are companies with low compliance even in the more developed markets such as the US. It is important to note that quality culture is company-specific and is dictated by the top management.

If quality doesn’t come from the top, it doesn’t flow through the ranks. While regulations need to be dynamic there should be one standard of quality for patients across markets. At the end of the day, regulators are looking for robust and consistent compliance across facilities.