This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.
Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.
When creating and managing electronic documents, document metadata deserves as much attention as document content. Firms that do so can improve compliance and even gain potential competitive advantage by realizing electronic documents (with appropriate metadata) as real business assets.
The Medicines and Healthcare Products Regulatory Agency (MHRA) published a revision to its 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016. The revision was a coordinated effort among the GCP, GDP, GLP, GMP, and GPvP inspection groups, reflecting a broad source of input.
According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.