1-3 April 2020
GMP News No. 558
20 May 2005
Barr Judgement on theInternet
It is the main objective of an OOS investigation tofind out the cause for a deviating analytical result (Was the mistake madeduring production or in the lab?). At the same time, the procedures set up inthe laboratory must withstand the accusation of "testing intocompliance", i.e. testing must not simply be repeated until acompliant result occurs. The accusation of "testing intocompliance" was one of the main points of criticism in the BarrJudgement. The Barr Judgement - also known as Wolin Judgement - is a verycomprehensive court decision that gives detailed answers to manyanalytical questions. One of them is: How many analytical tests arenecessary in order to disprove an OOS result? Even if the Barr Judgementis not quite up to date any more, it still represents a good source ofinformation for OOS questions.
All those who would like to get an insight into themost important lab-relevant statements of the Barr Judgement can find avery interesting summary when clicking here.
Although many years have passed since the BarrJudgement, OOS is still a topical issue as can be read in a Gold Sheetarticle titled "OOS Investigations Remain Key FDA Target" inthis year's March issue.
Concrete examples can be found in FDA Warning Letters:
"Confirmed OOS results for blend uniformity were obtained and nofailure investigation have been performed. …. Additionally, there was noevaluation of the impact of these failures on other batches of thisproduct currently on the market."
"Inadequate method validation in that OOS findings were discardedwithout investigation the cause of the OOS results and analytical data wasselectively reported."
According to the March issue of the Gold Sheet, oneof the main points in the references to failure investigation in WarningLetters is that the scope of failure investigation is not wide enough.Today the Agency expects e.g. that, when investigating process or productdeviations, failure investigation is also performed on other batches inorder to find out whether other batches of the same product are alsoaffected.
|Learn everything you need to know about the GMP-compliant handling of OOSresults at the international ECA Education Course Out-of-SpecificationResults taking place in Prague on 8 and 9 June 2005. On 10 June, anadditional interactive workshop deals with the conduct of failureinvestigation. Click here for thedetailed invitation programme.|
PS: All participants of this GMP Education Course will receive thecomplete Barr Judgement in electronic format.