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. Control: An evaluation to indicateRead MoreProduction Line ( Oral Liquids ) Essay1734 Words   |  7 Pagesas elixirs were also known, they were prepared by the ingredient soaking in spirit then straining the product, elixirs were thicker and stronger than tinctures. Drug discovery in the past was based on observation while there are different advanced tools that enable further studies and investigations till knew drugs are formed. Packaging was in the past in glass bottles closed with cork. Products: Trade Name Generic Name Type Use Mode of administer. MARVIT Palmitate,Ascorbic acid,VitaminRead MoreFood Safety: Cube-Sized Foods for Space Flights Essay911 Words   |  4 Pages HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product (FDA, 2014). In 1959, Pillsbury Company joined NASA as contractor and began working on cube-sized foods for space flights (Sperber, 2009). There were problems producing foods that would not deteriorate in space and provide the necessaryRead MoreOutline Of A And Bound Water On The Molecular And Cellular Interactions Of Peg Modified Drugs1544 Words   |  7 PagesReference: Parag Kohle et al, Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations http://www.bioprocessintl.com/upstream-processing/biochemicals-raw-materials/pegylation-of-biologics-340623/#CIT0015 Question 2: (Dr. Zhou) 5 marks Briefly describe the important processes in lyophilization and what are the main objectives of â€Å"freezing step†? Lyophilization is the process of removing water and/or solvents from a product by the method of sublimation andRead MoreProject Charter Example1602 Words   |  7 Pageslog-in, reporting analytical results, billing, and other related operations. | |Purpose/ Business Need: |As a result of the increased use of various high throughput technologies in virtually all areas of biological research, | | |sophisticated software is needed to help research and diagnostic laboratories manage, analyze, and organize complex data. In | | |addition, core technology facilitiesRead MoreThe Philosophy Of Medical Industry956 Words   |  4 PagesMedical product in general could be a life-threatening if it is not made in a perfect environment. The philosophy of medical industry depends on the efficacy of the product and it’s effect directly to the human body. Accordingly, the governments, stakeholders, scientists and all people who are involved to the industry field needs a road map to guide them for a product without fault or adverse events might happen which resulting from the inadvertent errors. Therefore, the idea of quality has beenRead MoreFood Protection Pl Essential For Food Safety1319 Words   |  6 Pagesconditions and hygienic practices. It is imperative that food manufacturers, processors, distributors, and all food related stakeholders develop a food protection plan to safe guard themselves from lawsuits and to be able to show that their food products are safe for human consum ption. It is the duty of the state to develop their own food safety plans and work together with all food related stakeholders to ensure compliance. Key words: food protection plan, food safety, health and safety. Introduction:Read MoreInteractive Organ And Tissue Printing975 Words   |  4 Pages2014) Bioprinted heart valve 3dprint.com Challenges with Integration of 3D Biomaterials into Electronic Health Record (EHR) Materials likely fall under biological drugs (Sinha Gunjan, 2014) Systems need to further evolve Systems must capture administration of biomaterials Unique barcodes to scan biological materials Connects administered product to patient?s EHR (ENGELBERG CENTER, 2013) Challenges with Integration of 3D Biomaterials into Electronic Health Record (EHR) Cont.? Tracking of adverseRead MoreFood Contamination Caused By Microorganisms1364 Words   |  6 Pagesindustries for the control of food safety hazards. HACCP is a preventative approach to food safety and designs measurements to reduce risks to a safe level. This facilitates the move towards a preventative quality assurance approach within a food business and reduces the traditional reliance on end-product inspection and testing. There are seven principles of HACCP that need to be used and implemented in any food industry throughout the world. †¢ Conduct a hazard analysis †¢ Identify critical control pointsRead MoreShould Fda Promote More Process Analytical Technology And Quality By Design Approaches For More Successful Impact On Manufacturers 1477 Words   |  6 PagesProcess Analytical Technology and Quality by Design approaches for more successful impact on manufacturers’ ability to maintain consistent quality? The Process analytical technology (PAT) and Quality by design (QbD) approaches are used to create quality in a product. Each approach offers manufacturers the framework to create consistent quality and potential to increase efficiency in the production of a drug product. The two approaches offer some key issues: increased product knowledge and understanding