Building the base for ‘good’ data integrity

The Indian pharmaceutical industry has been inundated by a substantial number of regulatory inspections, especially from US Food and Drug Administration (US FDA) and other prominent regulatory authorities such as UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada. The challenges arising here may be daunting but the emphasis has been to steadily shift to awareness and compliance with data integrity. In our last article, we covered the regulatory requirements, coverage of laws and issues around observational letters and inspections to set the context. Now, we will cover the issues faced during the manufacturing process of drug products.

Manufacturing as a process in the pharmaceutical sector has taken a vast leap with the help of innovative manufacturing equipment, end-to-end automated plants i.e. continuous manufacturing, skilled workforce and others. But the advent of technological advancements has led to a unique challenge of auditable data being available at all times.

Understanding the gaps

Data integrity non-compliance in manufacturing processes may not be as easy to discover and resolve in comparison with, for instance violations in financial or statutory processes. Here, there are usually tremendous amounts of systems and data reviews involved to identify data integrity issues in the batch manufacturing and ancillary records, which differ across products and organizations. The documentary trail associated with raw material movement, manufacturing process flow, manufacturing equipment validation and operation, equipment and plant cleaning records etc. are vital data points which ensure the production activities are carried out as per defined protocols and duly recorded.

Regulators have often kept a close watch on data getting generated as part of manufacturing processes while undertaking documentary reviews. This enables them to uncover instances of data integrity issues in the manufacturing processes. Failure to follow established procedures for control of all pages in the batch production records, non-compliance of training procedures by manufacturing personnel are some instances that have already made their way to the warning letters and inspection reports issued by global regulators.

The trend of inspection observations may reflect inadequate controls over analytical records in the Quality Control department as an area of concern. However, the lack of data integrity in the manufacturing process is equally alarming since the regulatory authorities have rights to access and review the production process. There have been cases where regulators have methodically highlighted data integrity and other issues in production process. Companies should note that the regulators require accurate and complete information across the lifecycle of a drug and which is not limited to just ‘critical’ activities such as drug testing and stability.

Need for remediation

Companies need to adopt a combination of proactive measures to close any gaps in their manufacturing processes and lower chances of any non-compliance. These include,

  • A well-defined Standard Operating Procedure (SOP) which is properly communicated, training provided for and is easy to follow. Well defined SOPs can help reduce data integrity issues and instil confidence in the company during regulatory reviews.
  • A robust data integrity review covering manufacturing processes
  • Increase reliance on automation and rigorous in-house as well as external trainings for production personnel
  • Conduct vigilant internal Quality Assurance inspections and independent checks of manufacturing facilities by expert third party consultants.

These actions can have a positive and lasting impact on the concerns that management as well as their Boards can have over data integrity assurance. A consistent and focused overview of the manufacturing activities can help drug manufacturers in India build a better roadmap to compliance.

(The article is the second of a two part series on data integrity.)

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