Where Does GMP Training Come From? A Brief History of Pharmaceutical RegulationMarch 1, 2016
Today, many of us take for granted that when we use a medication, we are certain that all of the contents inside the package are written out on its label. We know that our pharmaceuticals are safe and that they have been properly manufactured, tested, and labelled by dedicated professionals with GMP training.
But what was life like before there were good manufacturing practises? Before strict regulations were in place and trained professionals knew how to properly test products for consistency and safety?
Read on to learn what Canada’s pharmaceutical industry was like before regulation, and find out how important GMP professionals are to keeping Canadians safe and healthy.
A Brief Look at Pharmaceuticals in Canada Before GMP Training
Before Canada had good manufacturing practices, pharmaceuticals were very different than they are today. Without regulation, medicines could be purchased without a prescription. What’s more alarming is that some medication contained ingredients like cocaine, heroin, and opium—and such ingredients were rarely listed on labels.
This understandably led to many health problems. In fact, according to some estimates, more Canadians became addicted to opiates through prescription medications than through illegal channels like opium dens.
Fortunately, by the early 1900s, government officials started to realise that regulations were important, and that establishing good manufacturing practices was essential to keeping Canadians safe and healthy.
GMP Training and the First Guidelines Implemented in Canada
One of the first guidelines to be implemented in Canada was the Proprietary and Patent Medicine Act of 1908, which made it mandatory for manufacturers to list the presence of ingredients like heroin and morphine in “secret-formula” drugs. Additionally, cocaine was banned as an ingredient in pharmaceutical products.
This early legislation helped pave the way for further regulation and early GMP training. In fact, by 1920, the government of Canada had created the Department of Health, as well as the more detailed and comprehensive Food and Drugs Act. This act helped establish even stricter licensing regulations for drugs.
Between the 1920s and 1950s, the Food and Drugs act was amended several times in order to give the government the ability to limit the sale of drugs, and to require that each new drug submit data on its safety before it could be advertised.
How the Thalidomide Tragedy Lead to GMP Reforms in Canada
While early regulations did help to improve the safety of pharmaceutical products, they still weren’t as thorough as they are today. One example of Canada’s lax regulations was the thalidomide tragedy.
During the late 1950s and early 1960s, a new drug known as thalidomide hit markets. It was marketed as a sleep aid as well as a safe medication to ease the symptoms of morning sickness in pregnant women. Unfortunately, this so-called “wonder drug” was soon found to cause serious birth defects in newborns.
In their GMP online training program, students will learn that any adverse reaction must be reported immediately so that harmful medications can be recalled as soon as possible.
In countries like the UK, thalidomide was quickly pulled off of store shelves. However, in Canada, thalidomide wasn’t recalled until three months later—making a terrible tragedy even worse.
Fortunately, Health Canada soon learned from its mistakes. It notes that “The thalidomide tragedy prompted a complete revision of the regulations to strengthen the Department’s regulatory abilities. The revision marked the first appearance of the requirement for manufacturers to submit evidence of efficacy in seeking a Notice of Compliance.”
As a result, new drugs go through more rigorous testing now than ever before, ensuring Canadians are safer and healthier.
Do you want the flexibility of taking your GMP course online?
Learn how AAPS can help you start your rewarding GMP career.