Skipping Test in Pharmaceutical Industry

Skip or Periodic Testing

Periodic or skip testing is the performance of specified tests at release on pre-selected batches and / or at predetermined intervals, rather than on a batch-to-batch basis with the understanding that those batches not being tested still must meet all acceptance criteria established for that product. 

 

This represents a less than full schedule of testing and should therefore be justified and presented to and approved by the regulatory authority prior to implementation. 

 

When tested, any failure to meet acceptance criteria established for the periodic test should be handled by proper notification of the appropriate regulatory authority(ies).

 

If these data demonstrate a need to restore routine testing, then batch by batch release testing should be reinstated. Market surveillance and market authorization department have to be notified

 

ICHQ6B (Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products) does not address skip testing (reduced/ partial testing).

 

Addressed in EU-PIC/S GMP, chapter 5.35 Can be defined as “Partial repetition of tests for incoming materials”.

 

EDQM FAQs / CEP

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

Answer:

– 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. 

 

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. 

 

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 marketin authorisation application(s) for the medicinal product(s) in which a CEP is included.

 

Ph. Eur. : Skip Testing is Possible?

PhEur. 9.0 1.1. General Statements

Demonstration of compliance with the Pharmacopoeia:

(1) An article is not of Pharmacopoeia quality unless it complies with all requirements stated in the monograph. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality on the basis of ist design, together with ist control strategy and data derived , for example, from validation studies of the manufacturing process.

 

Read also:

• Process Validation in Pharmaceutical Industry
• In-Process Control Procedure in Pharmaceutical Industry