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?
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting. It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the ISPE Foundation and offers a look at the 2019 Facility of the Year Award (FOYA) category winners...
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
The ISPE Foundation® awarded 14 Student Travel Grants to bring 14 students to the 2018 ISPE Annual Meeting & Expo. Investing in the next generation of pharmaceutical engineers is a goal of the Foundation, which was formed in 2018.