Qualification testing of medical products
Pursuant to applicable Russian legislation, the procedure for bringing a new medical product to market entails conformance with a number of serious conditions. The final stage before the product starts getting stocked on pharmacy shelves is its obtainment of a registration certificate (RC). Prior to that, however, the product must undergo a lengthy series of evaluation procedures.
Once the product’s composition has been developed and adjusted, the manufacturer starts working on organizing mass production. From that very moment, all of the manufacturer’s activities come under the state’s strict control. The first batch of mass-produced product must undergo mandatory qualification testing.
Testing of medical products for the purposes of qualification
The main purpose of organizing qualification testing is to evaluate the manufacturer’s preparedness to proceed with the mass production of its product on an industrial scale. This testing is conducted for the first batch of product the manufacturer produces, which is also known as the pilot batch. In order to arrange for such testing, the company must contact an authorized organization accredited by Roszdravnadzor.
The Center for the Registration of Medical Products holds a valid accreditation certificate and offers services aimed at the performance of qualification testing on medical products. This testing is organized in compliance with the requirements of the national standards GOST R 15.013-2016 and GOST R 15.301-2016. It is conducted in the following sequence:
- creation of a special commission tasked with organizing and conducting the required tests;
- development of a control program, including the methodology for evaluating the product’s properties;
- analysis of documents pertaining to the medical product;
- preparation of the required equipment, which must pass mandatory inspection and calibration;
- performance of a qualification test of the product batch;
- compilation of a report on the findings of the completed tests, per the standard form;
- issuance of a decision on the testing result and compilation of a confirming document in the form of an act on qualification testing.
The result of the completed work will be considered positive if the products from the pilot batch have confirmed their conformance with all of the requirements reflected in the respective program. The manufacturer must also obtain positive evaluations according to select parameters: the fitting of the production process with the required equipment and achievement of stable characteristics within the scope of the production run. The characteristics binding on conformance evaluation are prescribed in the respective design and technical documentation.
