StudentShare solutions
Triangle menu

Good Manufacturing Practices - Case Study Example

Extract of sample
Good Manufacturing Practices

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. 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, ...Show more

Summary

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…
Author : qlindgren
Good Manufacturing Practices essay example
Read Text Preview
Save Your Time for More Important Things
Let us write or edit the case study on your topic
"Good Manufacturing Practices"
with a personal 20% discount.
Grab the best paper

Related Essays

Corporate Social Responsibility and the Corporate Ethics in relation to an Australian manufacturing company
The paper involves the investigation of various issues regarding CSR while entering a global market place for the Australian company. The corporate ethics and the corporate social responsibility have been studied in this paper. Various CSR issues have been discussed in the paper to analyze the need of CSR in global outsourcing.
12 pages (3000 words) Case Study
Draper Manufacturing

The author states that Draper manufacturing does not seem to be facing any racial issue but business challenges. Although there is no doubt that the current workforce working in the company is diverse and belongs to different races, yet the cause of contention between or among them does not represent their personal views over the racial issues.

1 pages (250 words) Case Study
Case History: Acme Manufacturing Company

The author says that this report was not a priority and Steve should not have spent so much time on it. Being rested for his busy day ahead would make more sense. When he arrived at work, he took time to stop and chat with a friend, which made him even later. His workday was supposed to start at 8:00 and he didn’t arrive at his office until 9:00.

2 pages (500 words) Case Study
Nike and International Labor Practices
It has diversified from shoes into apparel and sports equipment. In the high-end shoe market they are the most dominant brand. They further innovated through their ability to brand and market the shoes as a status symbol. Nike created the concept of the $100 pair of tennis shoes.
8 pages (2000 words) Case Study
Toyota Manufacturing
This paper is a review of the strategic capability of the Toyota manufacturing process. The TPS is known for its optimum use of resources. Hence the explanation of the manufacturing process will also include this factor with reference to cost efficiency. In drawbacks or absence (if any) of crucial elements will also be looked into.
3 pages (750 words) Case Study
Manufacturing Strategy
The first strategy is establishing strong links with the market. The EME industry has maintained a strong feedback loop with the processing, engineering, research, design and production functions. It has nurtured market sensitivity so as
2 pages (500 words) Case Study
Manufacturing Strategy
Therefore, what the company manufactures must be linked to the buying needs of the customers. The company managed to predict the response of the market to different colors and styles and created more recreational facilities, jobs and housing structures for its workers. Sport
2 pages (500 words) Case Study
Food Quality and Safty
he clients venerability to any form of contamination that may occur during the manufacturing or packaging processes, it is vital that manufacturers take the initiative ensure the food is free from any contaminants. Besides, the manufacturing standards are the sole source of
4 pages (1000 words) Case Study
Riordan Manufacturing
They therefore cannot limit their number of clients or the quantity of transported goods from other clients in order to ensure full service to Riordan. This means
1 pages (250 words) Case Study
BERTOS MANUFACTURING CORPORATION
Based on factors and other financial status, an inventory of chosen nations for the development is ready. The company anticipates expansion into abroad via direct ventures in foreign markets to sustain its parent corporation’s sales, Bertos
4 pages (1000 words) Case Study
Get a custom paper written
by a pro under your requirements!
Win a special DISCOUNT!
Put in your e-mail and click the button with your lucky finger
Your email
YOUR PRIZE:
Apply my DISCOUNT
Comments (0)
Rate this paper:
Thank you! Your comment has been sent and will be posted after moderation