03. Are all the tests referred to in a CEP to be performed for routine analysis/batch release?

The requirements for the performance of all the tests of a monograph or a CEP is not necessary a prerequisite for the release of a product but the requirements of European Pharmacopoeia, Chapter 1, “General Notices” (1.1. General Statements) that also applies to any additional test(s) included in a CEP, are alone authoritative in the event of doubt or dispute.