Commission Directive 2009/9/ECDangos y teitl llawn

E. CONTROL TESTS ON THE FINISHED PRODUCT

For all tests, the description of the techniques for analysing the finished product shall be set out in sufficiently precise detail for quality assessment.

The dossier shall include particulars relating to control tests on the finished product. Where appropriate monographs exist, if test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the pharmacopoeia of a Member State, are used, proof must be supplied that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned. The application for marketing authorisation shall list those tests, which are carried out on representative samples of each batch of finished product. The frequency of the tests, which are not carried out on each batch, shall be stated. Release limits shall be indicated.

Where available, chemical and biological reference material of the European Pharmacopoeia shall be used. If other reference preparations and standards are used, they shall be identified and described in detail.

1. General characteristics of the finished product

The tests of general characteristics shall, wherever applicable, relate to the control of average masses and maximum deviations, to mechanical, physical or chemical tests, physical characteristics such as density, pH, viscosity, etc. For each of these characteristics, specifications, with appropriate confidence limits, shall be established by the applicant in each particular case.

2. Identification of active substance(s)

Where necessary, a specific test for identification shall be carried out.

3. Batch titre or potency

A quantification of the active substance shall be carried out on each batch to show that each batch will contain the appropriate potency or titre to ensure its safety and efficacy.

4. Identification and assay of adjuvants

Insofar as testing procedures are available, the quantity and nature of the adjuvant and its components shall be verified on the finished product.

5. Identification and assay of excipient components

Insofar as is necessary, the excipient(s) shall be subject at least to identification tests.

An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.

6. Safety tests

Apart from the results of tests submitted in accordance with Part 3 of this Title (Safety Tests), particulars of the batch safety tests shall be submitted. These tests shall preferably be overdosage studies carried out in at least one of the most sensitive target species and by at least the recommended route of administration posing the greatest risk. Routine application of the batch safety test may be waived in the interests of animal welfare when a sufficient number of consecutive production batches have been produced and been found to comply with the test.

7. Sterility and purity test

Appropriate tests to demonstrate the absence of contamination by extraneous agents or other substances shall be carried out according to the nature of the immunological veterinary medicinal product, the method and the conditions of manufacture. If fewer tests than required by the relevant European Pharmacopoeia are routinely employed for each batch, the tests carried out shall be critical to the compliance with the monograph. Proof must be supplied that the immunological veterinary medicinal product would meet the requirements, if fully tested according to the monograph.

8. Residual humidity

Each batch of lyophilised product shall be tested for residual humidity.

9. Inactivation

For inactivated vaccines, a test to verify inactivation shall be carried out on the product in the final container unless it has been conducted at a late stage in-process.