14/15 September 2021
The ECA working group "Analytical Quality Control" has defined the development of a harmonised SOP on the handling of analytical deviations in the laboratory, including OOS, OOE and OOT results as first project.
In the first step of this project a SOP flowchart was developed and assessed by the ECA OOS Review Team in which more than 100 ECA members took part. In the second step a draft OOS SOP was developed using the already approved flowchart. Approximately 25 comments on this draft of an OOS SOP were received by members of the Review Team - with many detailed suggestions and comments that led to the preliminary OOS SOP version 1.0.
This OOS SOP was presented at the OOS Forum in Prague last year and made known to a wider audience. At the same time, alternative approaches of a GMP compliant handling of OOS results were discussed with representatives of different pharmaceutical companies.
It was decided at the ECA OOS Forum that the first ECA OOS SOP should concentrate on out of specification results. Originally, this SOP was also supposed to cover the handling of out of trend (OOT) results. The final version 2.0 of the ECA OOS SOP came into force on 14 August 2012.
The development of an SOP concerning out of trend (OOT) results is now planned as second project of the ECA QC Working Group. Regarding this, the ECA QC Working Group is looking for suggestions and ideas for the content of this next ECA OOT SOP.
The results of the ECA QC Working Group will be presented at ECA's OOS Training Course held from 9 to 10 April 2013 in Copenhagen, Denmark. Each participant will receive a copy of version 2.0 of the ECA OOS SOP. Furthermore, the actual regulatory requirements (FDA, MHRA, etc.) will be presented and discussed.