Art. 4 Protocol bij de Europese Overeenkomst betreffende de uitwisseling van geneesmiddelen van menselijke oorsprong, zoals gewijzigd

Human Normal Immunoglobulin is a preparation of the plasma proteins prepared from Whole Human Blood, containing the antibodies of normal adults. It is obtained from pooled liquid human plasma from not less than 1000 donors. The method of preparation used should be one which produces a material meeting the requirements herein prescribed and which prevents the transmission of serum hepatitis by the final product. In addition the method of preparation shall be such that the antibodies contained in the starting material shall be concentrated in an adequate amount in the final product. The procedure shall be shown, for each final preparation, to be satisfactory in this respect by titrating in the starting material and in the final product antibodies to at least one virus and one bacterial toxin. The antibodies chosen shall be those for which there are recognised methods of titration. During preparation no antiseptic or bacteriostatic substance shall be added; a suitable preservative and a stabilising agent may be added to the final preparation to maintain bacterial sterility and stability of the final product. The final product is issued as a solution in which the immunoglobulin concentration shall be between 100 and 170 gram per litre. Identification By precipitation tests with specific antisera, it must be shown to contain only human plasma proteins. By electrophoresis, using the moving boundary technique under acceptable and appropriate conditions, not less than 90% of the mass of the proteins have the mobility of the gamma component of the globulins of normal human plasma. Stability - Both before and after heating the final solution at 37° C for 7 days there should be no visible evidence of precipitation or turbidity. It is advisable also to carry out tests using an ultracentrifugation method to determine the extent of degradation of the product to smaller molecular weight components. The method used should be one approved by the national control authority. Acidity - The pH of the final solution shall be 6.8 + 0.4 when measured at a temperature of 15 to 25° C in a solution diluted to a protein concentration of l0 gram per litre by means of a solution containing 0.15 mole sodium chloride per litre. Sterility - The final product shall be sterile when examined by a suitable bacteriological method. Storage - Human Immunoglobulin solution must be kept in a sterile container, sealed so as to exclude micro-organisms, protected from light and stored at a temperature of 4° to 6° C. Labelling - The label on the container shall give all the information shown on the model label (Annex 5). The date of preparation is the date of filling the final container.

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