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By Mike Dingle, TSI Field Application Specialist
“Data integrity” refers to the completeness, consistency and accuracy of data. It is a top priority of large pharmaceutical manufacturers. Regulatory inspectors worldwide increasingly focus on it.
One might assume this is a result of a change in Good Manufacturing Practices (GMPs), but basic data integrity requirements have always been an integral part of regulations. What has changed is the way regulatory agencies perform inspections, making the review of data management practices key. This has led to a surge in audit findings associated with records and recordkeeping.
Simplifying Compliance and ALCOA+
Not surprisingly, pharmaceutical manufacturers are looking for ways to simplify compliance. Fortunately, regulatory agencies and professional organizations have released numerous guidance documents in recent years. Many guides reference “ALCOA+.” ALCOA+ identifies the characteristics data must have to ensure data integrity. The acronym stands for: Attributable, Legible, Contemporaneous, Original, and Accurate, with Complete, Consistent, Enduring, and Available covered by the “+”.
Like any other GMP test, airborne particulate testing must follow ALCOA+ principles, but compliance can vary depending on risk. For example, a small manufacturer of a non-sterile drug may be able to meet data integrity requirements using a paper-based system with instrument printouts. This has been common practice for decades. However, a large manufacturer of an aseptic product may view such manual record keeping as too risky, and require a more automated process that maintains all records in an electronic system.
TSI Portable Particle Counters offer the flexibility to meet a range of data integrity requirements. Whether enabling built-in printer capability or operating in highly automated data integrity mode, TSI particle counters help our customers comply with ALCOA+ principles and FDA 21 CFR Part 11 requirements for electronic records.