APPLICATION

In general, the process of verifying and evaluating the fulfilment of the GLP principles by an IE comprises, in a first phase, the application for entry into the NMP/GLP of the IPQ, followed by an inspection phase, being concluded by the issuance of a certificate of compliance with good laboratory practice. Thus, the applicant testing facility must initiate the process by submitting an application form to IPQ, requesting verification and assessment of compliance with the GLP.

Following this request, details of the test facility (layout of the facilities, types of studies carried out, staff, organization charts or others) will be requested. In order to obtain relevant additional information, a pre-inspection could be foreseen, normally carried out up to 3 months after receipt of the request.

It is a mandatory requirement to carry out the inspection, that the applicant testing facility is carrying out activities / studies in a GLP environment, and / or shows the completion of a completed study.

The test facilities carrying out studies on chemical products in the various areas, may be interested in entering the NMP/GLP for the following reasons: (1) the legislation in force requires that the studies carried out by the test facility be carried out in compliance with the GLP; (2) test facility customers (sponsors) require that they have a GLP Compliance Certificate, issued by the competent National Monitoring Authority, even if the legislation does not clearly specify it; (3) the test facility is interested in contracts in an area for which legislation requires compliance with GLP.

In general, all test facilities in the NMP/GLP are inspected with a maximum frequency of two years.

Any test facility already included in the NMP/GLP can request a change in its area of expertise, simply by making the request to IPQ, through the GLP working group .

The process of verifying / monitoring compliance with the GLP principles involves the payment of the respective costs, which are described in the IPQ GLP Price Regulation.

Communications with the test facility will preferably be carried out electronically, unless the latter does not have the necessary means or object with reason. Until otherwise indicated, electronic communications addressed to the GLP working group should be addressed to the email address: BPL@ipq.pt

Request the application form and instructions through: bpl@ipq.pt