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Today we will be talking about the A Brief History of GMP | When Was GMP Introduced in The World | Why do We Need GMP?
Good manufacturing practices and I would like to start with this segment.
It doesn’t get any more fundamental, as I will talk about the history of good manufacturing practice and the tragedies that led to its birth!
The article will be appealing to industry experts, novices, and complete outsiders!
You will be amazed to learn how much has changed in the last 100 years in comparison to the history of humankind.
You’ll also see how safer our life has become thanks to GMP.
I will give a short overview of GMP, and then we will travel 120 years back in time.
So, let’s start at the beginning.
Why do we need GMP?
Let me ask you a question – when you swallow a painkiller to ease your headache after a long night out, or a stressful day at work, do you ever doubt the pill’s effect?
Do you ever feel that you are playing Russian roulette, choosing a tablet from the package, fearing that it might kill you?
I hope that you answered “No” to those questions, and if you did, you need to thank GMP for that.
Or at least the people who made it a law.
Because if not for GMP, your answer would most certainly be “Yes.” For those of you who are entirely new to the pharmaceutical industry,
I will start with a short overview of what is GMP?
GMP is a collection of guidelines, which must be complied with while manufacturing pharmaceutical products, medical devices, cosmetics, and food.
Those guidelines are there to ensure that the consumer will get high quality and safe to use products.
When a company manufactures a batch of 100, 00 pills, according to GMP, they can be sure that each tablet is identical.
If there is a problem, they should ideally be able to detect it in time before it reaches the consumers.
To achieve those high standards, the GMP requires companies to have robust quality systems in place that monitor the smallest changes, every deviation, and documentation.
Manufacturers are obligated to have state of the art manufacturing facilities that are operated by highly skilled workers in a hygienic environment.
Also, every step in the production, including who, did what, and when must be documented and fully traceable.
The quality control and quality assurance departments oversee each significant step, according to their responsibility.
If all the checkpoints fail, a drug manufacturer must be ready to receive complaints and recall its products at any moment.
There is much, much more behind GMP, and the full list of requirements is long and may vary a bit from country to country, and from product to product, but this should be enough for you to grasp the significance of GMP.
And again, the guidelines are law and must be obeyed even in developing countries!
If an establishment disregards them, it is not allowed to sell its products, and if people get hurt, it means jail time.
Now, how did GMP come to be?
To answer this question, we need to jump into the TARDIS.
Or a time machine, for those of you who didn’t spend much of their evenings watching Sci-Fi TV Shows, and travel to a few points in time.
Our first destination is the USA, and the year is 1900.
People already had hospitals, vaccines, antiseptics, and drugs, but no real oversight, as Food and Drug Administration didn’t exist yet!
It was an excellent time for miracle workers and traveling healers!
They sold exceptional elixirs on every corner that could cure anything, from headaches to cancer!
They worked wonders on humans and animals alike!
Needless to say, that some of the products were unsanitary, while others contained dangerous poison-like-substances or opioids.
Unfortunately, those fraud miracle workers were not the only problem, because there were no regulations also for real drug production,
Which led to a chain of events that would change all of that!
But one year later, things started to change!
In 1901 St. Louis Board of Health, in the USA, produced a vaccine against diphtheria from the blood that they had taken from a horse named Jim.
They then discovered that Jim was infected with tetanus and killed him.
But it was a shame to waste perfectly good blood, so they continued to use the serum for diphtheria vaccines.
As a result, 13 children died from contaminated injections.
In a non-related case from the same year, nine children died from contaminated smallpox vaccines.
Then, many deaths too late, it became clear how important it is to use high-quality raw materials for the production of drugs.
That led to the formation of The Biologics Control Act, which became effective in 1902.
The act established a board to oversee the implementation of regulations of biological products.
It also required that all products be labeled accurately with the name of the product and the address and license number of the manufacturer.
The act was the first milestone for the establishment of the FDA, but it required another push to get there.
A book called The Jungle public opinion for change.
The book was a novel, written by Upton Sinclair.
The book talked about the exploits of immigrants in the country.
The hero of the book was Jurgis Rudkus, a Lithuanian immigrant whose family slowly decayed physically and mentally because of the plant conditions in the country.
His father dies because of unsafe work conditions in a meatpacking plant, and his son dies from food poisoning.
He also wrote about unsanitary conditions in which animals were slaughtered and processed and the practice of selling rotten or diseased meat to the public.
He also reported that ground meat sometimes contained remains of poisoned rats and even unfortunate workers who fell into the machinery.
Although it was a novel, the public became highly concerned with several passages exposing health violations and unsanitary practices.
The uproar reached President Roosevelt, who agreed with some of Sinclair’s conclusions.
His administration created the Pure Food and Drug Act, which was a series of significant consumer protection laws.
To uphold those laws, the administration established the Bureau of Chemistry.
The regulations required manufacturers to list active ingredients on the label of a drug’s packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary.
The Bureau of Chemistry became the U.S. Food and Drug Administration.
It was apparent for the FDA that The Biologics Control and The Pure Food and Drug Acts were not enough?
They gave no jurisdiction over cosmetics, medical devices, or advertising, and forced no standards for foods.
Highlight around 100 dangerous, deceptive, or worthless products that the FDA lacked authority to remove from the market. Because the exhibition was so shocking, it received the name the “American Chamber of Horrors.”
The public outrage led to the formation of the Bureau of chemistry the same Bureau would later become the FDA WHO in 1963 released the medical exhibition that earned.
The American Chamber of horrors exhibit included a wound supporter that could puncture the uterus is inserted incorrectly a weight-loss drug.
The drug caused death a hair remover that caused the baldness even if not used on the head you couldn’t find there are also lotions and creams.
That could cause mercury poisoning and hair dyes that could cause lead poisoning in an eyelash dye that could lead to blindness the exhibit reached.
The White House’s tension but the government decided to overlook it and created no new legislation to fix the problems and it took many more tragedies to bring real change the first one had to do with sulfanilamide.
It is an antibacterial organic compound used to in reducing infections first prepared in nineteen hundred and eight.
The from a steel company as a Massingill company created a new preparation of Sulfanilamide
They used ethylene glycol is a solvent and called it alexia sulfanilamide D G is poisonous to humans.
But the company’s chief pharmacist and a chemist were not aware of this as there were no regulations for drug development and clinical trials.
They just released the product to the market completely untested the company’s elixir caused one of the most significant mass poisonings of the 20th century leading to the death of 107 people many of them children.
Because of this event, the American Congress passed the federal Food Drug and Cosmetic Act for the first time companies had to prove that their products were safe before marketing like them
But this act was not enough to ensure reliable production methods that allow avoiding cross-contamination and unfortunately led to the following scenario to develop sulfathiazole was an antimicrobial medicine.
Which the company Winthrop Eagles chemical used to produce during manufacturing in the year 1941 they managed to contaminate each tablet of the product with about 350 milligrams of phenobarbital a drug for epilepsy killing hundreds of people.
This catastrophe led FDA to revise manufacturing and quality control requirements, but it alone didn’t cut it as well.
It took another world-scale event, to bring a real change that finally gifts us GMP.
It all started in 1956, in Europe, when a drug name Thalidomide came to market.
The company, Chemie Grünenthal, marketed it as a mild sleeping pill.
It also reduced morning sickness, so it became popular with pregnant women.
Unfortunately, the pre-clinical trials were lacking at the time, and the scientists didn’t test the drug on pregnant animals.
Only years later,
Doctors could connect the drug to about ten thousand cases of congenital disabilities, where babies were born with Malformed Limbs.
This event caused massive concern in the USA.
It has become a law and found its way to America’s code of federal regulations, under section 21 parts 210 and 211.
Finally, the FDA could regulate clinical trials and require drugs to be tested in animals before people.
It also put investigators responsible for supervising medications understudy.
Manufacturers couldn’t bring a product to the market anymore without proof of safety and efficacy, and they were required to report unexpected adverse events.
The regulations also contained the minimum conditions for facilities, controls to be used during manufacturing, processing, packing, or holding of a drug.
Drugs have to meet the requirements of the act as to safety and quality.
They must have the identity, strength, and purity characteristics that meet approved specifications.
The World Health Organisation accepted the American GMP as an integral part of its Certification Scheme on the quality of pharmaceutical products.
Since then, More than 100 countries have incorporated the WHO GMP provisions into their national medicines laws, and many more countries have adopted its regulations and approach in defining their local GMP requirements.
GMP for drugs was substantially revised and expanded to medical devices as well with 21 CFR 820.
The regulations governed the methods used in and the facilities, as well as the controls used for the design, manufacture, packaging, labelling, storage, installation, and servicing of all finished medical devices intended for human use.
The American government finalized the Good Laboratory Practices, to regulate nonclinical laboratory studies for future potentially registered drugs.
The journey of the GMP doesn’t end here.
Since its formation, there were many setbacks and problems, but it always keeps developing!
And that’s why we have the term cGMP – Current GMP.
It means that you have to keep learning and continuously improve the quality systems in the company.
Nowadays, GMP is a common practice worldwide, and people rarely get hurt from harmful drugs.
It took about 80 years of trial and error and many catastrophes to create GMP.
But it is a drop in the sea in comparison to human history.
For tens of thousands of years, the life expectancy of people in the world was about 30 years old.
But in the last 120 years, it more than doubled itself!
And GMP plays a crucial role in that!
Printed in 21 CFR 110. Specific GMPs were also included and printed in 21 CFR Parts 100 through 169 for:
Quality control procedures for the nutrient content of infant formula (21 CFR 106).
Thermally processed low-acid canned foods in hermetically sealed containers (21 CFR 113).
Acidified foods (21 CFR 114).
Bottled drinking water (21 CFR 129)
In July of 2002,
FDA formed a Food GMP Modernization Working Group to examine the effectiveness of current food GMPs given the many changes that have occurred in the food industry since 1986. The Working Group has been researching the impact of food GMPs on food safety, as well as on the impact (including economic consequences) of revised regulations. Part of the group’s current effort, as of
In June 2004,
Is to find out which elements of the food GMPs are critical to retaining and which should be improved. FDA is now holding public meetings to obtain public comments to assist in this effort.
Of course, it has to do with science, but because of GLP and GMP, only one of ten thousand molecules would become a drug.
It makes companies work harder and better to achieve potent and safe drugs.
It also pushes companies to develop computer software that would simulate in hours or minutes what would have otherwise taken years in the lab.
Therefore, the future looks bright and healthy for humankind, thanks to GMP, which will always keep progressing and improving.
I hope you enjoyed this article “A Brief History of GMP | When Was GMP Introduced in The World | Why do We Need GMP?” and found it informative!
If you did, share it with someone who might also find it interesting!
Stay compliant, and see you in the next segment!