19-21 May 2021
An article Focus on Quality in the journal Spectroscopy from November 2013 describes the risk assessment for instruments and computer-based systems in the analytical laboratory.
In the USP chapter < 1058 > analytical instruments are divided into the 3 groups A, B and C. Chapter < 1058 > defines the criteria for each group. However, it is left open how these 3 groups are to be managed in the laboratory.
For the industry and for supervisory authorities the currently widely used and recognized standard for the validation of computerized systems in the laboratory with regard to software is the GAMP® Good Practice Guide (2nd Edition, 2012). However, for the laboratory not all points at USP < 1058 > and the GAMP® Guide do match.
Currently the USP chapter < 1058 > is under revision. It is expected that in the future a consistent approach is provided. But at this point it is not, and therefore the question comes up how one should proceed today - according to < 1058 > or in accordance with GAMP®?
This question is discussed in the Focus on Quality article by Burgess and McDowall. In the article the authors propose a somewhat more detailed model for the qualification and validation for the three groups (A/B/C) of USP chapter < 1058 >. In addition, they introduce additional sub-groups for the risk assessment regarding groups B and C.
It is a simple, hierarchical evaluation model they propose and which can be used to determine the extent of the qualification or validation with which the laboratory can check whether the deployed instruments are suitable for the intended purpose under the actual conditions of use within the laboratory.
The idea is that by using 15 simple Yes/No questions six decision points are reached which can be used to determine the extent of qualification activities.
Find more information in the article An Integrated Risk Assessment for Analytical Instruments and Computerized Laboratory Systems.
GAMP is a trademark of ISPE - www.ispe.org.