Monday, January 6, 2020

Essay on Quality Assurance for Biological Products

A biological preparation that improves immunity to a particular disease is known as a vaccine. A vaccine contains an agent that would stimulate the body’s immune system. The immune system will recognize the agent as â€Å"foreign† and destroy it, once destroyed, the body will keep a record of it so the immune system can more easily recognize and destroy any of these microorganisms that it later encounters. The agent in the vaccine, resembling a disease-causing microorganism, is often made from a weakened or killed form of the microbe, toxin, or one of its surface proteins (6). Vaccines have no guarantee that it will bring complete protection for a disease. This is mainly because the host’s immune system simply does not respond enough, if not at†¦show more content†¦Once detected, the next step would be to prepare the vaccine strain so that the virus will be adapted for use in manufacturing vaccine. The vaccine virus is mixed with a standard laboratory vi rus strain and grown together in order make the virus less dangerous and better able to grow in hen’s eggs. In about three weeks, a hybrid is formed where the inner component is the laboratory strain, and the outer component is the pandemic strain. Once completed, the vaccine strain is distributed to vaccine manufacturers. The manufacturers will inject the vaccine virus into thousands of eggs, eggs are incubated for two to three days during which the virus multiplies. The egg white, which now contains millions of vaccine virus, is then harvested, and the virus is then separated from the egg white (7). Producing each batch, or lot, of antigen takes approximately two weeks, and a new batch can be started every few days. The next step would be the quality control, and this can only begin once the reagents for testing the vaccine are supplied by WHO laboratories. Quality control will test each batch and verify the sterility the bulk antigen. Then the batch is diluted, packaged, l abeled, and shipped out. So that this production of vaccine in terms of manufacturing runs smoothly and effectively, the WHO publishes a document on the general requirements for manufacturing establishments and control laboratories in 1966. The aim of the document published by WHO is to provideShow MoreRelatedQuality Assurance : The Act Of Giving Confidence1655 Words   |  7 PagesThe phrases â€Å"quality assurance† and â€Å"quality control† are frequently used interchangeably to refer to methods of ensuring the quality of a service or product. These phrases, however, have different meanings. â€Å"ï » ¿ Assurance: The act of giving confidence, the state of being certain or the act of making certain. Quality Assurance: The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled. 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