Replicate strategy for testing in pharmaceutical quality control, risk of out-of-specification (OOS) results and the revised FDA OOS Guidance (10471)

In May 2022, the FDA published a revision of its guidance on the investigation of OOS results. The revised version contains a number of clarifications and cross-references to the Code of Federal Regulations; essentially, the text remains the same as in the version of 2006. The chapter on "Cautions", which has repeatedly given rise to misinterpretations in the past, has been rewritten. This concerns specified replicate determinations with averaging and the requirement that the mean value should be compared with the specification as the "final analytical result", as it is also described in chapter <1010> of the USP. In the revised version, the cases in which, from the point of view of the authors of the guidance, it is permissible for single values to be OOS in specified replicate determinations, are now restricted to those cases in which one sample is analysed several times (after sample preparation has been carried out). In all other cases, all single values of a multiple determination must comply with the specification. Such a view contradicts the essence of replicate determination and the respective strategy, which is not only to reduce analytical variability, but also to improve the quality of the analytical result, which represents an estimate of the true value. A good opportunity to revisit the topic of single determinations, double determinations and replicate determinations, i.e. the replication strategy, as well as the investigation and evaluation of OOS results in pharmaceutical quality control (small molecules).

Duration: ca. 180 minutes
Module 1 (90') – Replicate strategy | Module 2 (90') Investigation and evaluation of OOS results
Language of presentation: English | Slides: English

...more from your speaker Dr. Markus Veit...

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