A string of new guidance documents have made it clear that data integrity (DI) remains high on the agenda of regulatory authorities around the world and this has become a global issue. DI in the context of pharma manufacturing has led to a rising number of regulatory enforcement actions citing failures in the recording and review of manufacturing data. In some cases violations have led to written warning letters and even bans on imports from some manufacturing facilities.
The extent of draft guidances and what DI is all about is reviewed. However, while these directives clearly apply to drug product and do not impose requirements directly on excipient manufacturers or distributors, it is evident that drug product manufacturers will start to ask questions of their suppliers on their approaches to data integrity.
With this is mind, the IPEC Federation is considering what might be appropriate for its membership to consider regarding data integrity.  Good Data Management influences the integrity of all data generated and recorded by a manufacturer and robust systems should ensure that data is accurate, complete and reliable. So, regardless of regulation or components being supplied which are used in drug products, appropriate data integrity ‘behaviours’ make for good business practice and contribute to patient safety.
Whilst the guidances referenced are still draft and it is difficult at this stage to take anything more than a general position, the IPEC Federation is considering publishing a statement on this important topic later this year, to help its members understand how to address this growing issue.

Excipients Insight August 2016