Out of specification

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Out of Specification ( OOS ) is an expression that is only used in the German-speaking area in the context of FDA regulations . A definition can be found in the document “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”. This means that for the scope of this document, “OOS” means all test results that are outside of the specified specifications or acceptance criteria. The treatment of out of spec results or - in other words - deviations from the tolerance range (e.g. stipulated in a pharmacopoeia or another specification) is a central element of all quality assurance systems such as B. DIN EN ISO 9001 , GMP , GLP . In the case of content information for the drug acetylsalicylic acid (ASA), for example, the lower limit value G u ≥ 99.5% and the upper limit value G o ≤ 101.0% would be permissible according to the European Pharmacopoeia.

Consequences of OOS situations

Even if the measured value is within the calibrated measuring range, it may be an OOS result. This is the case, for example, in the pharmaceutical industry, when an impurity, which normally has a max. 0.1% is specified, suddenly 0.2% is represented in a batch . As a result, after a thorough review and verification of the measurement result, the manufactured product cannot be sold. The verification must ensure that the product really does not meet the requirements and that the measurement process was carried out correctly. As a result, it should be checked whether this product can be used for other applications with low specifications, whether the product can be purified or whether it must be disposed of. An OOS result can therefore be associated with considerable additional costs for a company.

OOS from a metrology perspective

Although the term OOS is used in the FDA documents, no FDA document actually defines what exactly is meant by OOS. In the above-mentioned FDA document, however, “outside-specification situations” and “not-within-specification situations” are equated, which is wrong from the metrological point of view , because between these two situations there is a difference of twice the underlying (extended ) There is measurement uncertainty .

See also

Individual evidence

  1. ↑ http://www.fda.gov/downloads/Drugs/Guidances/ucm070287.pdf . Chapter I, accessed October 17, 2014.
  2. ↑ European Pharmacopoeia. 6th edition. Deutscher Apotheker Verlag, Stuttgart 2008, ISBN 978-3-7692-3962-1 .
  3. ↑ European Pharmacopoeia. 6th edition. Deutscher Apotheker Verlag, Stuttgart 2008, ISBN 978-3-7692-3962-1 , pp. 1561–1562.
  4. ↑ ILAC G8: 03/2009 Guidelines on the Reporting of Compliance with Specification; PDF download . Retrieved March 15, 2015.