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What is the Different Types of Certifications in Pharma | GMP, GDP, FDA, CEP, More
We are talking about this, the GMP certificate, which proves your company is operating on GMP quality standards.
But as you can see this is not the only certificate that exists in the pharmaceutical industry.
Everyone within the pharmaceutical industry has something to do with these certificates, so it is good to understand what they are.
In this article, I am trying to explain what the differences are between the certificates.
Literally on all orders settled through our platform one or multiple of these certificates have been exchanged.
When you take medicines yourself, you want to be sure that they are safe. Obviously, you can’t test every single pill that comes out of the factory.
So, which certificates are required to ensure the safety of the ingredients in your medicine?
That’s a good question, which I’ll come back to later.
First of all, it’s important to understand that there are in fact two kinds of certificates:
Producer related And Product-related.
Producer related certificates
They are focused on the company itself.
Certificates that are about the company will investigate things such as: are all employees aware of the procedures that are in place.
How does the company deal with quality complaints?
How do they avoid mix-ups of product labels?
And what happens in case of an accident?
They are not bound to any specific product but are the general precautions and guidelines that are in place.
They are important to provide information about the product itself.
For example, how a certain ingredient is produced and tested,
Whether a particular batch is tested to the required product standards, and if it complies with all environmental- and ethical rules.
Most likely, these certificates will be different per each batch of produced API.
That’s it for the introduction to the world of quality certifications.
Let’s dive into them more specifically, starting off with the GMP certificate I mentioned earlier.
GMP stands for Good Manufacturing Practices and it basically means being able to consistently output a product with certain specifications and to have documented all steps in the process of doing so.
If there wasn’t such a system implemented, there would be no way of telling if a certain API or medicine has been produced according to the industry set quality standards.
That’s why the GMP system was introduced and is now the main standard in the pharmaceutical industry worldwide.
You might have seen that there are a couple of different types of GMP.
The WHO has its own guideline for GMP.
More than 100 countries have incorporated the WHO GMP guidelines into their national medicine law.
And many more countries have adopted the WHO approach by defining their own national GMP requirements, creating a local GMP.
Just as with the WHO GMP, it specifies the authority that has audited the company.
For example, to know the difference between a Chinese GMP certificate and an EU-GMP certificate, you have to check the difference in GMP requirements of both authorities.
It simply means the occurrence, and it says that the company complies with the most recent requirements/version of the GMP.
The next item on our agenda is the FDA.
The FDA, which stands for Food and Drug Administration, is one of the United States federal agencies.
When a company is (US) FDA approved, it means that the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like the FDA.
Most other countries have agencies that play a part in the national safety of pharmaceutical products.
These are some of the bigger ones that exist throughout the world we’re not quite done yet with the acronyms here because the next one we will cover is ISO.
The ISO isn’t specifically a pharmaceutical guideline. It stands for the International Organization for Standardization.
The organization promotes worldwide proprietary, industrial and commercial standards.
Organizations use the standard to demonstrate the ability to consistently meet customer and regulatory requirements.
The ISO system pays more attention to the management of the firm and places a number of reporting loops in the firm to ensure attention to issues.
In more recent history, the ISO has also introduced guidelines that focus on nature & the environment and a guideline that focuses on occupational health and safety.
When an API is imported into the European Union from elsewhere in the world, it should have written confirmation (WC).
A written confirmation is a document set up by the health authorities of the country where the API was manufactured.
After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide written confirmation.
These inspections will also have to regularly take place in the future.
Written Confirmations for API imports are not necessary when countries outside of the EU are included in an official list of countries that are equivalent to the EU in terms of GMP standards, inspections, and sanctions.
So, countries on this list are exempt from needing to have a WC.
GDP stands for Good Distribution Practice, and it’s a quality system for warehouses and distribution centers dedicated to pharmaceutical products and it focuses on the distribution of APIs and medicines.
It controls the whole process; from the moment a product leaves the manufacturer to the point where it reaches the end-user.
GDP for example checks if all documentation is present and if the goods are correctly stored.
With storage, it is important that the temperature is controlled and logged into a system.
Are you still with me? Good!
Let’s focus on the product-related certificates Let me ask you something.
What is Paracetamol?
You’ll probably know that it could help against your headache, but if you want to find out more about its properties and quality, you will have to check one of the international pharma books, like this one.
This is the European pharmacopoeia.
Here you’ll find information about the API Paracetamol such as that it should look white or almost white, how to store it, and more technical information on how to identify it and what to test for it to comply with that pharmacopeia.
This description is called a monograph.
The European Pharmacopoeia is not the only one.
In general, there will be lots of overlap between the different pharmacopoeia of a certain API.
The CoA, a certificate of analysis, contains the name of the monograph and its criteria, including the results obtained from laboratory tests for an individual batch of a product.
So, the CoA tells you whether or not a batch complies with the Pharma guidelines.
A DMF, the drug master file, is a document submitted to government agencies that contain all details of the manufacturing process of an API or medicine.
It includes information on the chemical properties of the API, the facilities that are used, the processes that are used, details on the packaging, storage, and more.
Basically, it’s the entire manufacturing process from start to finish.
In order to protect the intellectual property of the manufacturer, there is an open part of the DMF and a closed part that is confidential.
Countries may have different guidelines compared to other countries, that’s why different types of DMF exist.
For example, you may have a US DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, etc.
A Material Safety Data Sheet (MSDS) is a product-specific document with information about the safe use, handling, and processing of the product.
It contains detailed information about identification, chemical properties, health hazards, and other relevant information for professionals working with the product.
For example, it will tell you what to do when the product accidentally ends up in your eyes.
Internationally, there are different requirements for an MSDS and an MSDS issued in the USA will be different from one issued in China.
The GHS is a standard managed by the United Nations (UN) which provides a harmonized system on how the MSDS should be set up.
A CEP (also known as COS) is a certificate that proves that an API qualifies for that API monograph in the European Pharmacopoeia.
It basically links the monograph in the Ph. Eur. To the API itself.
A CEP is submitted by the manufacturer of the API as part of the market authorization process, and they will become the CEP holder of the document.
Being a European certificate, the CEP is granted by the EDQM (European Directorate for the Quality of Medicines & HealthCare) but is actually recognized by lots of other countries that are not in the European Union.
Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
The Kosher certification verifies that the ingredients and the production process comply with the standards of the kashrut, which is the Jewish dietary law, as defined in the Shulchan Aruch, a compilation of Jewish religious law.
It is important because it ensures the product is produced within the norms and values of the Jewish religion.
These are just a few of the certificates present in the pharmaceutical industry, but they are the ones we found most relevant for us.
Which certificates are necessary depends on things like the end-market of the medicine,
The type of medicine you produce, and the country of origin of the ingredients.
I’ve tried with the best of my knowledge to explain what the role of these certificates are and I hope you liked it.
If you do, please share, it will help us to create more articles like this.
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