How Did Pharmaceutical Quality Control Develop?

The process of creating medication has a long, rich history, dating back far beyond what we now consider to be the modern pharmaceutical industry. In the beginning, medications were compounded by tribal elders or village medicine making artisans, consisting of local herbs and other ingredients. While there was no official pharmaceutical quality control or pharmaceutical quality assurance at this time, the fact that only well-trained artisans were counted on for medicine speaks to the importance of quality in the process, even then. Since those times, dating back many thousands of years BC, medicine has become an industry, and today there are strict regulations in all areas of production and delivery. Below is a brief history of how quality control came to be in the pharmaceutical industry.

The "Wild West" Days of Pharmaceuticals

• From the late 18th century to the early years of the 20th century, medication was rarely if ever regulated, harkening back to the days of the Wild West, or any other great frontier. The problem at the time was two-fold; first, dangerous, addictive medications which are banned today could be purchased, often without a prescription, at many drug stores; second, that any person could market any concoction as a miracle cure, without any evidence to back up their claim. These problems, along with some others, led to a natural progression through which quality control became a concern. Still, it would take time, and great advances in the industry, to spur on true change.

The Early Days of Quality Control

• Things really started to change when pharmaceuticals went from a "mom and pop" type of industry to seriously big business. The key to this growth was the discovery of important medications like penicillin and insulin. These were some of the first medications to be truly mass produced and distributed, which made pharmaceutical quality control and pharmaceutical quality assurance a necessity in the industry. Organizations were formed and regulations introduced, all with the aim of ensuring the quality and safety of mass distributed medications.

Explosive Growth in the Pharmaceutical Industry

• As the 20th century wore on, new, extremely important medications were being discovered constantly. Many of the companies which started out as small businesses and grew with the advent of penicillin now turned into corporate behemoths. With scientific advances, medications were being synthesized and designed in labs. Some of these, of course, turned out to be dangerous and addictive, while others proved to help millions. Quality control became much easier with advanced lab equipment, while quality assurance had to become more robust in order to monitor both lab activities and manufacturing. By the later 20th century, no medication could be released to the public without passing stringent testing, and being monitored with quality control and assurance.

As technology and discovery continue to spur evolution in the pharmaceutical industry, you can expect quality control and assurance to evolve as well. There will always be a need for regulation, in order to protect companies and ensure patient safety.