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The Role of Quality Assurance and Quality Control in Clinical Research

19 DEC 2012
Career Path : Pharmaceutical Quality Control

Clinical research demands exact science and impeccable quality. Whether the end product is a scientific theory, a medical cure or a consumer product, if data is not reliable, thousands through to millions of dollars may be wasted, producing defective material or pursuing an incorrect avenue of study. In fact, in pharmaceutical quality control or matters of engineering, human lives can depend on getting drug dosages perfect and consistent, or structure and chemical composition exact.

 

What Is Clinical Research?

Clinical research is a several stage, highly controlled process in medical science, testing the effect of a drug, device or biological agent on human subjects. A pre-clinical stage concerns itself with animal or possibly cell culture tests, but everything up to clinical practice, the process of putting a treatment or product into use, falls under the label of research.

 

What is the Difference Between Quality Assurance and Quality Control?

Quality assurance is the various activities in a quality system, while quality control is more concerned with the outputs. Thus, quality assurance concerns itself with preventing mistakes before they happen, while quality control looks at the products produced by a system to check them for defects. While the two terms are applied synonymously in popular speech, there are essential differences to the two terms in science.

 

Drug development in particular generally goes through four stages to obtain approval from a country’s national body. Acronyms and exact regulations vary, from the FDA and EMA in the United States and the European Union, to the Canadian Health Canada. In every step, pharmaceutical quality control provides the necessary check to show all laws are being followed, and the thing being measured is actually what scientists think it is, including checking for cross contamination of test samples, but results submitted to regulatory bodies must demonstrate the methods used for quality assurance as a matter of due diligence.

 

Scientific research of all kinds also applies statistical methods, assuring that results that occur are not due to mere chance. All scientists receive training in both statistical methods and quality assurance and quality control, but research projects will usually have dedicated personnel double checking all principles are followed. These team members measure quantities, equipment function and quality, and keep track of all the variables that may go into a study. Clinical research laboratories, especially those involved in drug research, will also turn to external certification bodies to gain further reputable qualifications for their research facilities.

 

Health and Safety Inspectors also apply quality assurance and quality control to the laboratory and workers themselves, for their own protection. They make sure materials are being handled safely, with the correct protective equipment such as full coverage, non-slip foot gear and splash proof goggles.

 

 

Visit the Academy of Applied Pharmaceutical Sciences (AAPS) Inc. for more information on pharmaceutical quality control.