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Good Manufacturing Practices - Case Study Example

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Summary to case study on topic "Good Manufacturing Practices"
Good Manufacturing Practices (GMP) refers to the regulations propagated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (GMP institute, 2008). It is a universal believe that every time a person take a medicine for any purpose, it is the right medicine and is safe to use and that it will perform as intended…
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Download file "Good Manufacturing Practices" to see previous pages... I am working in a Japanese pharmaceutical company Takeda in Ireland. It is a research based largest pharmaceutical company in Japan and one of the global leaders of the industry. I consider it to be a privilage to be with such an esteemed organization. Basically, I am involved in dispensing raw materials and controlling coating process.
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The raw materials that are the basic ingredients of any medicine needs to be passed through GMP to be qualified, sourced properly, and tested before release into use. Though these regulations vary in different part of the world, they are responsible to creating business and compliance challenges.
Poor quality medicines or those medicines that are not manufactured using GMP can damage health. For instance, a poor quality medicine may contain toxic substances that have been unintentionally added, causing damage to health or even death. The use of GMP is absolutely necessary in each and every steps starting from selecting the raw materials till the finish product is sealed and packed properly. If the coating of the drug is not good, it may loose most of its valuable ingredients by the time it reaches the consumer. It is a well known fact that a medicine that contains little or none of the claimed ingredient will not have the planned therapeutic effect. I believe that failure to comply with GMP regulations can result in very serious costs as well as product recall, seizure, termination of manufacture, fines, and even imprisonment.

Every time we take a medicine we can have confidence that the medicine has been manufactured in accordance with GMP because it has today become a global standard. GMP along with expert assessment gives us a clear overview that every medicine is safe to use, will have the necessary efficiency and will be of the right quality (emeu.eu, N.D.). GMP or the recently updated cGMP, where the "c" corresponds to "current," remind manufacturers that they must utilize technologies and systems which are modern and abide by with the regulation. Under current GMP rules and regulations which is the latest version of GMP, it is the pharmaceutical manufacturer who is accountable for the entire operations (Saffron Media Pvt. Ltd., 2004).

There are a variety of practices that ensure quality: some of them are as follows: "raw materials quality declaration; maintaining correct substances all the way through the manufacturing process; standards for hygiene and safety; in-house testing; production and process controls; and warehousing and distribution" (Dietary Supplement Quality Initiative, 1999). I am responsible for dispensing raw materials and controlling coating process. As a result of following GMP my working environment is much more safe and efficient.

Additionally, these regulations require that manufacturers, processors, and packagers of drugs, to take positive steps to make sure that their products are secure, unadulterated, and effective. GMP regulations necessitate an extremely good manufacturing process, allow companies to reduce or even eliminate probable chances of contamination, mixups, and errors. Failure of companies to meet the terms with GMP can result in very serious costs.

Studies have shown that GMPs offer quality assurances that off-the-shelf testing cannot. In fact, ...Download file "Good Manufacturing Practices" to see next pagesRead More
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