Determination of quality criteria for candidate standard for anti-D immunoglobulin

Abstract

Quality control of medicines is an integral part of the technological cycle, obligatory for the release of products into public distribution. Both in Russia and abroad, when carrying out of laboratory testing of the preparations, it is prescribed to use the reference materials – the certified standard samples. Currently, it is important for the Russian pharmaceutical industry to provide the methods for evaluating the specific activity of human anti-D immunoglobulin with a national standard sample. Its production is impossible without the production of stabilized concentrate of anti-D antibodies and verifying the suitability of each batch for sale. This requires the establishment of specification requirements and the development of regulatory documentation.Aim is to define the quality criteria for candidate standard for anti-D immunoglobulin.Material and methods. The national and foreign normative bases in the field of quality control of blood products, manufacturing and application of biological standards of medicines were analyzed. Three series of lyophilized concentrate of anti-D antibodies were obtained and a laboratory-experimental study of their properties was carried out.Results and discussion. As a result of the work done, technical specifications were approved, including a list of consumer characteristics, a description of the methods for their assessment and relevant norms.Conclusions. The established requirements can become the basis for the releasing quality control of the candidate standard for anti-D immunoglobulin during its serial production.