Objective: To establish the universal electronic laboratory notebook (ELN) templates in laboratory information management system (LIMS) for dissolution tests in pharmaceutical testing laboratories. Methods: The testing methods and decision criteria of dissolution tests as per the monographs and general notice of dissolution test in ChP, EP, USP, and JP were investigated and compared. Based on the characteristics of the dissolution tests, the universal ELN templates were designed to be Microsoft® Excel® workbooks composed of a number of worksheets. The universal ELN template for dissolution test of HPLC method contains the following worksheets, i.e., worksheets of dissolution method, reagents, HPLC method, system suitability test, reference substances and dissolution results, while that of UV method includes the worksheets of dissolution method, reagents, UV method, blank solution, reference standards, and dissolution results. Necessary worksheet cells with adequate information are filled as per the quality standard, and equations using Excel functions such as IF, MOD, POWER, ROUNDDOWN, ROUND and COUNTIF, etc., are edited. The worksheet cells are then locked. The text type raw data should be introduced into the ELN cell by manual inputting or selecting from the drop down list, while the raw data acquired by analytical instruments could be transferred to the designated ELN cell via serial communication or ECM. The dissolution results are automatically calculated and rounded to integer by locked equations using these raw data, and whether the results comply with the requirements according to corresponding pharmacopoeia or not will be judged automatically in ELN. Results: The established universal ELN templates are of high practicability. The templates are applicable for the electronic recording for dissolution tests covering the testing methods of HPLC and UV, and the testing conclusion can be automatically drawn according to the stage-by-stage determination flowchart of dissolution test in ChP, EP, USP or JP. The utilization of validated universal ELN templates meets the requirements of data integrity, decreases the occurrence of the errors caused by manual calculation, data rounding and the result judging, and promotes testing efficiency. Conclusion: The universal ELN templates for dissolution tests, being flexible and convenient, can meet the demand of government pharmaceutical testing laboratories which have a wide variety and low repeatability of testing samples. The establishment of the ELN templates in this article can offer reference for other pharmaceutical testing laboratories.
PENG Ming, WU Xiao-luan, CHEN Xiao-ping, FAN Lin-lin, ZHANG Mei, LE Jian, YANG Mei-cheng, GU Song-qing
. Establishment of universal ELN templates in LIMS system for dissolution tests in pharmaceutical testing laboratories[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(3)
: 537
-546
.
DOI: 10.16155/j.0254-1793.2022.03.23
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