Quality Assurance and Quality Control in Medicine
Career Path : Pharmaceutical Quality Control
Medical staff at all levels, from part-time school nurse to master surgeon and from private practice to research laboratory, rely on good quality assurance and quality control. Whether engaging in vast clinical trials to bring a new drug to market or applying adhesive bandages to small abrasion, careful attention to detail and safety asserts itself as and essential a part of clinical research, manufacturing and even dispensing and sales.
The first stage all treatments must go through is the approval process. Nearly every country has a regulatory body that oversees the effectiveness of clinical research in testing new medicines and devices, which might be anything from a painkiller to an artificial heart, and includes testing old drugs for new uses. No drug may be sold or advertised as a cure for a problem without first proving itself in what is usually a four step process, almost exclusively following a course of animal testing for the protection of human subjects. In this stage, quality assurance and quality control are applied both to the material being studied, but also the methodologies of the study and the equipment used to measure it.
Drug and medical device manufacturing takes place in ultra-sterile, highly observed and documented facilities. Every piece of equipment must be in perfect repair and all interfering variables taken into account including temperature and ventilation, as well as the exact calibration of medical devices. Pharmaceutical quality control processes will be involved, catching errors before they occur and seeing to product consistency. This is also the case in all consumables that go in or on the human body, such as cosmetics or hygiene products, though laws vary by country. Though protecting trade secrets is important to every company, medical manufacturers must make a necessary sacrifice of privacy for consumer protection and reassurance that also extends to ingredient labeling on products.
Point of Sale (or Dispensing)
Whether a drug sold through a pharmacy or the medical facilities themselves, quality assurance and quality control maintain the same level of importance. Pharmacists must maintain clean facilities with measuring tools as accurate as research laboratories, while treatments facilities are held to strict standards, from oncology wards to hospital cafeterias. Finally even medical materials sold over the counter may be subjected to random sampling, both to ensure expiration dates and storage guidelines are being followed, and as a final stage of general quality control.
With so many layers of oversight, modern medicine has never been safer from contamination or manufacturing defects. It also leads to a booming industry in various sorts of inspector, from the civil servants and private contractors employed by regulation agencies overseeing and certifying everything, to embedded employees with training in fields ranging from pharmaceutical quality control to biological materials detection. Lastly, even lobby groups trying to make an industry change may also hire their own researchers to demonstrate a problem.
Visit the Academy of Applied Pharmaceutical Sciences (AAPS) Inc. for more information on clinical research.