iSpeak Blog

FDA Data Integrity Draft Guidance – Opportunity for Pharma Industry

Frances M. Zipp

Data integrity and its definition in the context of pharmaceutical manufacturing has been the subject of a lot of discussion in recent years. Manufacturing processes are highly complex, and every step generates data that must be recorded and reviewed, which is nothing new. Perhaps the recent uptick in enforcement actions related to data integrity can be attributed to the prevalence of computerized systems in both the laboratory and manufacturing systems in pharmaceutical companies. These systems are a relatively recent addition to the pharmaceutical industry.

Not so long ago, the paper results that were manually transcribed into laboratory notebooks and batch records could be destroyed without a trace if the results were not what was expected. With the advent of computer-controlled systems and their introduction into pharmaceutical plants, however, audit trails should exist for every operator and operation in the electronic record associated with an analysis or batch. Any discrepancies or issues are able to be revealed by self-audits of a firm’s laboratory and production systems. There is no special set of skills that an investigator needs to reveal these issues. It is incumbent upon firms, therefore, to have controls in place to review their data (and those of their suppliers), especially in this current enforcement climate. This will reveal any potential issues that might arise prior to an investigator from a regulatory authority uncovering it during an investigation Firms have long been waiting for guidance from regulators, which they have recently received, but it might not have been exactly what they were expecting.

The FDA Data Integrity Draft Guidance, issued in the form of questions and answers, clarifies the role of data integrity in execution of cGMPs and provides the current agency thinking on creation and handling of data in accordance with cGMP requirements. It contains a good amount of information that should be valuable to firms, regardless of their size or scope of products they manufacture. It also provides an explanation for recent FDA objections related to system suitability testing—specifically, that the samples (known as a secondary standard) used for validation must be from different batches than the test sample. While this guidance contains some useful and valuable information, it is not very prescriptive, and is hardly a road map for compliance. In that regard, industry groups are providing an opportunity for collaboration and planning.

The upcoming ISPE workshop should help create a road map for compliance, and help remind everyone in regulated industry that data is a product of all systems in a pharmaceutical plant throughout a product’s entire life cycle. On 5 June 2016, in conjunction with the ISPE/FDA/PQRI Quality Manufacturing conference, ISPE is organizing a Data Integrity workshop featuring a group of speakers from industry and FDA to discuss the role of data integrity in the entire product life cycle, from development through post-marketing. This half-day gathering will focus on key data integrity issues that affect the pharmaceutical product life cycle, such as the current regulatory environment, data governance, and corporate and regional culture.

This interactive event will identify and answer key questions surrounding current expectations, and will help firms implement internal controls to prevent data integrity issues.  Register today; we look forward to seeing you there!