Special Report: Data Integrity & Biopharmaceutical Manufacturing
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to citations for missing data, signatures, and date and time entries, to say nothing of the risks posed to patient safety.
Since the Sarbanes-Oxley Act was passed by the US Congress in 2002, a greater emphasis has been placed on data integrity in biopharmaceutical manufacturing. Changes in 21 CFR part 11, ICH mandates, and European and US pharmacopoeias have also influenced the need to maintain data in formats that are both sacrosanct and inviolate.
Today, the need for data integrity is foremost in our documentation, analytical records, measurements, and requirements. Data integrity demonstrates that processes operate within proscribed limits, and ensures that we can archive, retrieve, and show the data for any state of the process at any given moment in time.
This Special Report provides insights into how we manage, use, and incorporate data to protect the integrity of all values, measurements, and processes—as well as comply with regulatory mandates and guidances.
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical industry today.
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are analysts working differently today? Have they suddenly started disregarding the importance of the data they generate? Can regulators no longer trust laboratory results?
The fifth Pharma 4.0™ conference was held December 2022 in Vienna, Austria, in combination with the Aseptic Processing conference. Nearly 500 participants attended either in person or online to learn about the latest developments.
ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.
In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system1
1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised...