Effects of quality management on domestic and global competition

¶ … Quality Management on Domestic and Global Competition

Describe OR diagram a process or procedure that is similar between the organizations

The most important process in developing medicines is conducting research and clinical trials. This is mandatory to avoid legal problems and also is the method of ensuring that the derived drug or medicine is effective and without any side effects. The company Pfizer is into R&D for finding new medicines for challenging diseases. The clinical trials of discovered medicines are a process that is very crucial for the medicine to be approved. The regulations are such that there are regulations regarding the clinical trials and rights of the participants. While Pfizer is a research-based company that develops drugs after trial, the Par Pharmaceutical is more of a generic drug company. (Par Pharmaceuticals, 2011)

The difference is that in the case of a generic drug the clinical trials would have already been conducted by the original discovering company. The generic drugs are patent free drug formulas that become so after a lapse of the original patent. Pfizer is also a generic drug manufacturer and both are thus able to give out low cost drugs in the market. Par Pharmaceutical confines itself to the market in the United States and is recently gone global. In the case of Pfizer, it is a multinational drug company. Each company has its own policies and positions regarding the clinical trial. The process in the clinical trial is long and elaborate. (Clinical Trials. Gov, 2007)

The selective use of the medicine discovered of patient volunteers who meet the conditions are of two types-interventional and observational. In the interventional type the volunteers are subject to the treatment and the results and the reactions measured and the result shows the success of the formulation. In the second type that is the observational the volunteers are just observed without the induction of the drug and comparisons created. The protocols for the trial is common for all companies and participants and all such trials in the U.S. come under the purview of the Institutional Review Board -- IRB and thus institutions that conduct or support biomedical research involving people must have the IRB that approves the research. (Clinical Trials. Gov, 2007)

Clinical trials have different phases. In the first the experimental drug or treatment is confined to a very small group and is tested for safety, dosage range, and side effects. On establishing this, the research moves to the second step a larger group of over one hundred people to see its effect in a larger group. In the third phase the number increase to more than three thousand which can effectively provide a conclusion on the trial. In the last phase the drug is perfected and sent for market study. (Clinical Trials. Gov, 2007) This is the process by which pharmacy companies introduce new drugs. In the case of all companies the FDA certification is got after this process. The need for clinical research is less for generic drugs but nevertheless may be needed for improvements.

2) Explain why the process or procedure produces a competitive product or service in the domestic and global markets

Other than the mandatory requirements the clinical trials are part of the quality management system. The credibility of the company depends on the effectiveness of the medicine it sells. So for both the companies the results of clinical trials and the opinions from the market and the medical fraternity is very important in improving the quality of the medicine and also bring about a better product to gain a better market share. The clinical trials thus help bring high-quality products to market not only in the therapeutic side of pharmaceuticals. For the generic drug segments that are a niche, high-barrier-to-entry products like the ones dealt with by Par Pharmaceutical the clinical trials are also important to establish the niche in the first place.

3) Explain how quality management affects the position of the companies in the domestic and global market