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Ethics Essay

1852 words - 8 pages

NAME : Siwanja Fungai C

REG NUMBER : H1214427X

COURSE : Biotechnology quality assurance and control

LECTURER : Dr Musengi

ASSSIGNMENT : One

QUESTION: Write an essay on the importance of quality in the biotechnology industry {25}.
According to ISO:900, quality is the degree to which a commodity meets the requirements of a customer at the start of its life. The product should provide total and continuous satisfaction to the consumer while the consumer is using it. For an organization to function, it needs customers. For this reason the organization must understand the expectations of the customer and be able to meet then and or even exceed them ...view middle of the document...

These play important roles in both assuring compliance to current good manufacturing practices (GMP) and ensuring the consistency, quality, and safety of the manufactured product (Federici et al, 1991).
Quality control is a procedure or set of procedures intended to ensure that a manufactured product adheres to a defined set of quality criteria or meets the requirements of the customer.it emphasizes on testing of products to uncover defects which are reported to the management resulting in a decision to allow the product into the market or not releasing it. Generally, quality control is the responsibility of operational units and in implementing it quality is infused into the outputs and verified as they are being generated. Quality assurance is a procedure or set of procedures intended to ensure that a product or service under development that is, before work is complete, meets specified requirements. It is process orientated thus it attempts to stabilize production and associated processes to avoid, or at least minimize, issues which led to the defects in the first place. It involves the use of Standard Operating Procedures (SOPs), systems for entering results, validation and calibration of equipment and external assessment from which the organization is accredited to (BS EN ISO 9000:2009).
Biotechnological processes which are used in the manufacture of products are quite complex an long such that one cannot master all the steps. An example is the manufacture of insulin a therapeutic protein using recombinant E.coli. The process starts from creating the recombinant E.coli to culturing then downstream processing. Thus, use of SOPs in a production plant is very crucial in this industry. They provide a stepwise guideline to which a laboratory technician can simply follow without any hustles resulting in the attainment of a consistent quality product being manufactured despite who performed the production process. Entering results is very important in a biotechnology industry (Federici, 1994). Take for example a customer has a query on the test results that the company has conducted in testing foot and mouth disease from a sample he has submitted. The results can be easily retained from this kind of system thus ensuring reliability and good reputation of the company.
Customers expect companies to deliver products that are of quality that is they should be consistency from the previous purchase of product. Thus quality is an important aspect in satisfying and retaining loyal customers as an organization can not solely thrive on new customers. This shows that the testing of raw materials that have been procured for use in the manufacturing process is of great importance as raw materials also have a great influence on the quality of the product outcome.
With the growing loss of faith by consumers in genetically modified animals and food crops meant for human consumption, a company cannot afford to lose its reputation it has built due to production...

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