Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
Instrument changes in analytical methods of pharmaceutical quality control are required to maintain release analytics over decades, yet typically pose a challenge. We designed an efficient instrument comparability study to gain a comprehensive understanding of potential performance differences between instruments and therefore rationalize the risk assessment and decision process for a path forward. The results may either point out whether a full or partial re-validation is necessary or whether a science-based bridging can be pursued based on the data generated in the study. The study design is universally applicable to a substantial range of release analytical methods. In a straightforward setup of two experiments with the new instrument, a statistically meaningful data set is generated for comparison with available historical or validation data of the original instrument. In a Good Manufacturing Practice (GMP) environment, we realized the study design a first benchmark in imaged capillary isoelectric focusing (icIEF) analytics, comparing the ICE3 and Maurice C instruments. The core-study confirmed equal or better performance of Maurice C in all parameters and serves as a basis for seamless continuation of release measurements on Maurice C.