Introduction to Pharmaceutical Data Items and Their Structure
Structuring the data used in pharmaceutical reporting will reduce the time needed to create reports, eliminate the manual (human) verification of data tables, and ensure error-free submissions. The use of structured data is particularly powerful in Module 3, which includes large, complex sets of data related to product quality. Using a structured approach to data from source to submission improves data integrity, follows ALCOA+, and is a foundation for working towards the ISPE Pharma 4.0™️ initiative[i].
Throughout the CGMP data life cycle, CDER and CBER stress the importance of data integrity. “…data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA). Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. System design and controls should enable easy detection of errors, omissions, and aberrant results throughout the data’s life cycle.”[ii]
With internal structure, each data item is unique, related to other data items, and can be part of an overall taxonomy or ontology[iii]. A structured data item can be reused in many places and still be a single item. If something about the item changes, the change will be seen “everywhere” because it is a single, unique data item used in more than one location.
In this first article of the series, we use the example of drug stability reporting to consider problems with a lack of internal structure at the data item level and how structure can reduce or eliminate those problems. As part of the analytical development domain of Chemistry, Manufacturing, and Controls (CMC), stability testing generates large data sets that are used in complex data tables. CMC reports, including stability, are included in Module 3 (Fig. 1) of the Common Technical Document (CTD)[iv].