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Answer:

Periodic or skip testing consists in the performance of specified performing tests on pre-selected batches or at predetermined intervals rather than 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 It is to be reminded that the Ph. Eur. General Notices underline stress that performing all the tests of in the monograph is not necessarily a prerequisite for assessing compliance with the Pharmacopoeia Ph. Eur. before release of a product. The assurance Assurance that a product is of Pharmacopoeia Ph. Eur. quality may be obtained from data derived, for example, from validation studies of the manufacturing process and from in-process controls. Parametric release in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the PharmacopoeiaPh. 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 officially binding. The EDQM has does not to 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) where in which a CEP is included.