Does skip testing need to be declared in CEP application dossier?

Answer:

Periodic or skip testing consists of performing tests on pre-selected batches or at predetermined intervals instead of on a batch-to-batch basis, with the understanding that:

- All batches must fully comply with the monograph specifications as well as with all additional tests mentioned on the certificate of suitability, if tested.

- Critical tests shall be conducted routinely on every batch of the substance.

Applicants are reminded that the Ph. Eur. General Notices stress that performing all the tests in the monograph is not necessarily a prerequisite for assessing compliance with the Ph. Eur. before release of a product. Assurance that a product is of Ph. Eur. quality may be obtained from data derived, for example, from validation studies of the manufacturing process. Parametric release in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Ph. Eur.

The certificate of suitability certifies that a given substance is suitably controlled by the tests of the relevant monograph(s), plus additional test(s) as necessary. It describes the specifications that have been approved during the evaluation and that are binding. The EDQM does not take a position on skip testing in the context of the evaluation of a dossier for a CEP. Skip testing has to be approved by the relevant authority reviewing marketing authorisation application(s) for the medicinal product(s) in which a CEP is included.