index.htm. 6. Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend. 3
OOT results do not follow the expected trend. – They are not necessarily Out-of-Specification. • OOT results are somewhat of a rogue topic. – United States vs. Barr Laboratories (1993) forced an FDA draft guidance on OOS. – This guidance footnotes that similar guidance can be used to examine OOT results. – But there is
Since the Barr case the US FDA has led the way in defining standards for the investigation of OOS results, culminating in the publication of the final Guidance for. Industry on this subject in October 2006. This American guidance has become the generally accepted global standard but in 2010 the UK MHRA published its
analysis. The results highlight the need for issuing a. regulatory confirmed guideline for identification of. OOT results for ongoing stability data. The two terms out-of-trend (OOT) and out-of specification (OOS). results are in many cases confused by pharmaceutical. companies and regulatory agencies. OOT results are defined.
2 Jun 2013 OOT results are defined as a stability result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study (1). The guideline, however, does not define the process for identification of OOT results in stability data.
Practical Advice on how to Identify OOE and OOT Results. ? Laboratory Data Management Guidance Out of Expectation. (OOE) and Out of Trend (OOT) Results Compiled by ECA's. Analytical Quality Control Working Group (70 pages). ? Methods and Approaches for Detecting. - Out of Expectation (OOE) Data. - Out of
9 Apr 2016 Home QA & QC SOP on handling of Out of trend (OOT) Scope:This procedure shall be applicable for handling of out of trend of stability sample at quality control of pharmaceutical company name with location. Responsibility:QC personnel shall be responsible to follow the procedure as
Although the FDA guidance indicates in a footnote that much of the guidance presented for OOS can be used to examine OOT results, there is no clearly established legal or regulatory basis to require consideration of data within specification but not following expected trends. Identification of Out-of-Trend Results. Avoiding
24 Sep 2014 An article in PharmTech from June 2013 (by Trajkovic-Jolevska et. al) deals with the methods to identify Out-of-Trend (OOT) results in ongoing stability studies. The conclusion of this article is the statement that there is a tremendous need for a regulatory Guideline on OOT results in stability studies. This is

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February 2018