The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) recently released its GMP data integrity definitions and guidance document for the pharma industry. This document consists of MHRA's expectations from the pharma companies while dealing with the matters on data integrity.
This move further strengthens and highlights the importance regulatory agencies are giving to the compliance of data integrity as a fundamental element in ensuring the quality of the medicines. It is understood that this guidance is intended to complement existing EU GMP, and should be read in conjunction with national medicines legislation and the GMP standards.
Interestingly, MHRA from the start of 2014 had directed all the pharma manufacturers, importers and contract laboratories, as part of their self-inspection programme, to review the effectiveness of their governance systems to ensure data integrity and traceability, in accordance with Chapter 9 of EU GMP.
It was also expected that in addition to having their own governance systems, companies outsourcing activities should verify the adequacy of comparable systems at the contract acceptor. Highly placed source from the industry stressed that by coming out with this guidance document, the MHRA has established the importance it gives to data integrity and their future course while examining a case.
The source pointed out that now while the industry does have a reference point to clarify their doubts, lack of sensitisation among the stakeholders on the importance of complying to the same needs to be addressed to avoid complication.
In the recent past, Indian pharma companies had been increasingly getting unwanted attention from the international drug regulatory agencies like US FDA due to various data integrity issues. They have repeatedly questioned Indian companies' ability to demonstrate the integrity and security of laboratory data, records, results and information are prerequisites for any successful inspection of any GMP regulated quality control laboratory.
Kaushik Desai a senior industry expert, stressed that this is a strategic move by the MHRA aimed at guiding the industry to understand and incorporate data integrity for ensuring quality. If taken in stride, this guidance document can go a long way in understanding the complex system of the data integrity procedures and utilising it within the organisation.
The document elucidates that the data governance system should be integral to the pharma quality system described in EU GMP. As such, manufacturers and analytical laboratories are not expected to implement a forensic approach to data checking, but instead design and operate a system which provides an acceptable state of control based on the data integrity risk, and which is fully documented with supporting rationale.
It is understood that the data integrity requirements apply equally to manual i.e paper and electronic data. Their guidance document states that manufacturers and analytical laboratories should be aware that reverting from automated or computerised to manual or paper-based systems will not in itself remove the need for data integrity controls.
It also states that in addition to an overarching data governance system, which should include relevant policies and staff training in the importance of data integrity, consideration should be given to the organisational and technical controls applied to different areas of the quality system. The degree of effort and resource applied to the organisational and technical control of data lifecycle elements should be commensurate with its criticality in terms of impact to product quality attributes.
Data may be generated by a paper-based record of a manual observation, or in terms of equipment, a spectrum of simple machines through to complex highly configurable computerised systems. Further it also states that systems should be designed in a way that encourages compliance with the principles of data integrity.