For the purposes ofadmission and batch control of testsera and testantigens a pool of human sera was used to prepare a reference preparation for the determination of IgG, lgA f IgM and complement factor C3. The content was calibrated by radial immunodiffusion (RID) against two WHO-Standards and declared in International Units (IU). This preparation was used äs a probe in different commercial Systems for the determination of IgG, IgA, IgM and C3. The methods of measurement included RID, turbidimetry, nephelometry, kinetic nephelometry and fluorescence. The results showed that for different methods one has to work with different nominal values for the reference preparation.
In addition to marketing authorisation, inspection and pharmacovigilance the experimental testing within the CAP programme provides another important instrument of assessing and testing centrally authorised medicinal products. Coordinated activities in European member states and institutions--including planning, sampling, lab testing, reporting and assessment of results--allow us to establish an effective quality control system for this group of innovative medicinal products. By means of using existing networks and national structures, unnecessary parallel sampling and testing can be avoided, and limited resources can be used in a better way. The CAP programme is an independent test and surveillance programme, which demonstrates the high quality of centrally authorised medicinal products in the EU/EEA. That way, it strengthens the confidence of patients and the public in these innovative medicinal products. Furthermore, it enables OMCLs to gain experience with new sensitive analytical methods, which can also be used in other areas, for example for the identification of counterfeits or the assessment of biosimilars and generics.
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