AAPS 2017 Development and Validation of a cGMP Compliant Particulate Characterization Database

Authors & Contributors

Reference databases catalog data and information for known materials, process and product related materials, and archived foreign particulate. In a simple process with few particulates and few reference materials, a hard copy catalog with pictures and spectra may suffice. However, for operations that generate numerous particulate with many lots and products, digital data storage is key to an efficient particulate characterization program. Reference databases can contain optical information, spectral files, chemical data and important information associated with non-conforming particles. This allows for mining of data, to aid in comparison to known materials, as well as to determine common lots, facilities, times, or any other information that may foster root cause analysis. Digital data management systems fall within the overall compliance strategy of the organization. Digital data is considered an electronic record and should be considered as such when collecting, analyzing, and using the information. The development and validation of a cGMP database will be discussed in this presentation, in addition to utility of the advanced data storage, comparison and mining capabilities