GMP News No. 558
20 May 2005
Barr Judgement on the Internet
It is the main objective of an OOS investigation to find out the cause for a deviating analytical result (Was the mistake made during production or in the lab?). At the same time, the procedures set up in the laboratory must withstand the accusation of "testing into compliance", i.e. testing must not simply be repeated until a compliant result occurs. The accusation of "testing into compliance" was one of the main points of criticism in the Barr Judgement. The Barr Judgement - also known as Wolin Judgement - is a very comprehensive court decision that gives detailed answers to many analytical questions. One of them is: How many analytical tests are necessary in order to disprove an OOS result? Even if the Barr Judgement is not quite up to date any more, it still represents a good source of information for OOS questions.
All those who would like to get an insight into the most important lab-relevant statements of the Barr Judgement can find a very interesting summary when clicking here.
Although many years have passed since the Barr Judgement, OOS is still a topical issue as can be read in a Gold Sheet article titled "OOS Investigations Remain Key FDA Target" in this year's March issue.
Concrete examples can be found in FDA Warning Letters:
"Confirmed OOS results for blend uniformity were obtained and no failure investigation have been performed. . Additionally, there was no evaluation of the impact of these failures on other batches of this product currently on the market."
"Inadequate method validation in that OOS findings were discarded without investigation the cause of the OOS results and analytical data was selectively reported."
According to the March issue of the Gold Sheet, one
of the main points in the references to failure investigation in Warning
Letters is that the scope of failure investigation is not wide enough.
Today the Agency expects e.g. that, when investigating process or product
deviations, failure investigation is also performed on other batches in
order to find out whether other batches of the same product are also
Learn everything you need to know about the GMP-compliant handling of OOS
results at the international ECA Education Course Out-of-Specification
Results taking place in Prague on 8 and 9 June 2005. On 10 June, an
additional interactive workshop deals with the conduct of failure
investigation. Click here for the
detailed invitation programme.
PS: All participants of this GMP Education Course will receive the complete Barr Judgement in electronic format.