A Brief History of GMP Regulations

Allan Murphy Bruun + Follow

Pre-Validated eQMS for Life Sciences – Save Time and Stay Compliant
Published Mar 22, 2023

Good Manufacturing Practices (GMP) are incorporated into the quality management
system to help ensure companies manufacture their products with high and uniform quality
according to controlled and documented processes.

But they didn’t always exist…

Unfortunately, the history of GMP has had many tragedies over the years. GMP regulations
and guidelines were created first of all to prevent some major issues from happening again.

In life sciences, more specifically in the pharmaceutical industry, the application of modern
drug regulation tracks back to 1906 in the United States when the Bureau of Chemistry was
tasked to enforce the Food and Drug Act signed into law by the late President Theodore
Roosevelt.

At that time, children’s syrup and tonics contained alcohol, morphine, and heroin without any
description on the labels, addicting many people. The Food and Drug Act required dangerous
ingredients to be declared on the label, so adulterated and misbranded drugs became illegal.
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In 1927, the Bureau of Chemistry had a separate entity in charge of regulatory functions. This
was the Food, Drug and Insecticide Administration which eventually became the Food and
Drug Administration that we know today.

Around 10 years later, in 1937, a tragedy involving an antibiotic solution called Elixir
Sulfanilamide killed more than a hundred people. The drug was solubilized using a high level
of toxic raw material. This led to the enactment of the Federal Food, Drug, and Cosmetic Act
in the year 1938.

So, for the first time, companies were required to prove the safety of their drug products by
conducting pharmacological studies before marketing.

In the 1940s, the FDA implemented several sets of requirements we use until today in GMP
regulation. Pharmaceutical companies were required to test and certify the purity and
potency of drugs in 1941 and test their safety and effectiveness in 1945.

Meanwhile, in Europe, a new drug market for morning sickness called thalidomide was
related to birth defects in thousands of babies in 1962. In the 1970s, GMP requirements were
compiled in the EU GMP EudraLex volume 4. It is a comprehensive guide, including EU
regulations and international guidelines for good manufacturing practices for medicinal
products intended for human and veterinary use.

After the thalidomide tragedy, many regulatory authorities published GMP guides, such as
the World Health Organization (WHO) in 1969 and the United Kingdom in 1971.

It was in 1978 that the FDA created the regulations that became what we know today as 21
CFR Part 210, which specifies the current GMP in the manufacturing, processing, packing, or
holding of drugs. As well as the 21 CFR Part 211, specifying the current GMP for finished
pharmaceuticals.

Most recently, the International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) published guideline Q7, a GMP guide for active
pharmaceutical ingredients, in 2000.

As we can see, compliance with GMP requirements helps ensure the quality and safety of
drug products. GMP regulations and guidelines continued improving through the years to
incorporate the growing necessity of more requirements to prevent other tragedies.

Pharmaceutical companies with products under the GMP requirements must document
several manufacturing processes.

A Quality Management System (QMS) helps ensure these processes are organized and
properly controlled. It is important to have a QMS that reflects the GMP requirements to
achieve compliance.
The QMS can be a paper-based or hybrid system. However, manual paperwork is not the
most efficient or modern document management method. For instance, it can lead to lost
documents, unauthorized access to files, and be more time-consuming.

Pharmaceutical companies can benefit from an efficient Electronic Quality Management

System (eQMS) to help manage all processes and the high volume of data and documents
created during manufacturing.

Having an eQMS helps streamline and automate quality processes. It also supports
companies in achieving compliance with GMP requirements regarding document
management.

Curious to learn more?

You can keep learning about how GMP compliance is reflected in QMS and the role of
eQMS in our original article by accessing it HERE.

In this article, you will learn the following:

Defining GMP

Origin of GMP Requirements

Why Are GMP Regulations So Important?

Major GMP Regulatory Requirements

Role of an eQMS in Supporting Compliance With GMP Regulations

Gitok Ach 3w
Plant Manager at PT Sanbe Farma

Great Thank You

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