In order to ensure quality, safety, and efficacy of pharmaceuticals, an appropriate control of the capability of the manufacturing process (EU GMP Guide Part 1, Annex 15), as well as of the analytical performance (EU GMP Guide Part 1, Chapter 6, Quality Control (6.16), FDA Method Validation Guidance) is important, during the whole lifecycle. A regular evaluation is expected, e.g. as Annual Quality Review (FDA, 21CFR 211.180(e)) or Product Quality Review (EU GMP Guide 1.10). The importance of a monitoring of analytical performance to identify proactively failures and adverse trends is discussed in the FDA-Guidance „Analytical Procedures and Methods Validation for Drugs and Biologics“ (2015) and also in the draft of the new ICH guideline Q14 „Analytical procedure development“.
Unlike the rules established for investigation of results outside of specification (OOS), no detailed advice is provided by the authorities in case of results outside of expectation or outside of trends. However, this opens up the flexibility to establish suitable monitoring and trending programs of own choice.