ECA's Analytical Control Group Publishes Detailed Report on OOS Survey

As previously reported, the ECA Analytical Quality Control Group (AQCG) conducted a survey on Out-of-Specification (OOS) results earlier this year. The survey, which ran from February to April 2026 and collected a total of 169 responses, explored how organisations across the pharmaceutical industry approach OOS investigations in practice.

Following the recent publication of a short summary, a detailed report has now been prepared. It presents the individual results graphically and is supplemented by free-text comments from respondents. The report provides a comprehensive picture of current industry practice and highlights areas where participants identified gaps or called for additional regulatory guidance.

In addition, a short recorded discussion between Dr Markus Funk (Administration Manager of the AQCG) and Ms Margarita Sabater, a Board Member of the ECA AQCG who was closely involved in planning and evaluating the survey, is now available. During the discussion, Margarita Sabater addresses key questions arising from the findings, including the most significant gaps identified, areas to prioritise in a future revision of the ECA OOS guidance, and the overall message from the survey results.

Both the detailed report and the recorded discussion are available in the group's members’ area.