What is GMP, DMF, FDA, and CEP? The differences explained!
The pharmaceutical industry has some bureaucratic sides to it, but it’s for a good reason. In the end, most APIs and medicine are intended for taking care of patients. Keeping that in mind; manufacturers and distributors are required to live up to certain high standards set by, for example, international agreements, their local government, or other organizations. In this article, we will be handling the main types of certificates or documents as present in the pharmaceutical world.
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anWhat is GMP? (Good Manufacturing Practices)
GMP stands for Good Manufacturing Practices and is defined as “a system of manufacturing that guarantees reproducibility of product quality to set specifications”. Basically, it 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.
Different kinds of GMP / GMP is also known as:
cGMP (current GMP)
Current GMP means that the company complies with the most recent requirements/version of GMP.
WHO GMP (World Health Organization GMP)
The WHO has its own guideline for GMP. More than 100 countries have incorporated the WHO GMP provisions into their national medicine law, and many more countries have adopted its provisions and approach in defining their own national GMP requirements.
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.
If you have a deeper interest in GMP, check out our blog where we talk about GMP in detail and the differences between GMP/cGMP.
What is FDA? (Food and Drug Administration)
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows 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 FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products.
Some different kinds of organizations include:
- EMA (European Medicines Agency, European Union)
- MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- CDSCO (Central Drugs Standard Control Organization, India)
What is a DMF? (Drug Master File)
A drug master file is a document submitted to governmental bodies that contains all details of the manufacturing process of an API or medicine. This includes information on chemical properties of the API, the facilities used, the processes used, details on packaging, storage, et cetera. In order to protect the intellectual property of the manufacturer, this document is confidential.
Countries may have different guidance 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, et cetera.
What is ISO? (International Organization for Standardization)
ISO is the international organization for standardization. The organization promotes worldwide proprietary, industrial and commercial standards. Organizations use the standard to demonstrate the ability to consistently provide products and services that 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.
Different kinds of ISO:
ISO 9001:2015 (is a standard that specifies requirements for a quality management system)
ISO 14001:2015 (is a standard that focusses on managing environmental responsibilities)
ISO 22000:2018 (is a sector-specific standard that describes a specific process to develop a food safety management system)
- ISO 45001:2018 (is a new standard published in March 2018 that focuses on occupational health and safety. It is based on- and will be replacing the OHSAS 18001 standard over the period of 2018 – 2021)
What is a CoA? (Certificate of Analysis)
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example:
- Ph. Eur. | EP – (European Pharmacopoeia)
- USP – (United States Pharmacopeia)
- BP – (British Pharmacopoeia)
- JP – (Japanese Pharmacopoeia)
- ChP – (Chinese Pharmacopoeia, also known as PPRC)
- DAB – (German Pharmacopoeia)
- Ph.Fr. – (French Pharmacopoeia)
- IP – (Indian Pharmacopoeia)
In general, there will be lots of overlap between the different qualities of a certain API. Certain limit values can differ, according to the specific values set by different standards. A different monograph can also mean a different way of testing?
A technical data-sheet is not the same as a CoA, as it contains just the general product specifications and does not contain batch-specific results which the CoA does.
What is an MSDS? (Material Safety Data Sheet)
A Material Safety Data Sheet (MSDS) is a product-specific document that is intended as a reference work for safe use, handling, and processing of the product. It contains information such as identifiers, chemical properties, health hazards, precautionary statements, and other related information for professionals working with the product.
Internationally, there are different requirements for an MSDS and an MSDS issued in the USA will differ from one issued in China. However, in recent years more and more companies have updated their MSDS to a GHS system(Globally Harmonized System of Classification and Labelling of Chemicals). The GHS is a standard managed by the United Nations (UN) and sets a certain structure for an SDS (16 sections), general statements for health hazards, common symbols, signal words, et cetera.
MSDS is also known as:
- SDS (Safety Data Sheet)
- PSDS (Product Safety Data Sheet)
What is a CEP? (Certificate of Suitability)
A CEP (also known as COS) is a certificate that proves that an API qualifies to the relevant monograph of the European Pharmacopoeia. It 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 but is recognized by other countries or institutes such as the FDA in the US. 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.
This certification verifies that the ingredients and the production process comply with the standards of kashrut (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.
The Halal certificate is a document that guarantees that products and services are suitable for the Muslim population. When something is Halal-certified, It meets the requirements of Islamic law and is, therefore, suitable for consumption for the population that practices Islam.
What does BSE/TSE mean?
Bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, is a neurodegenerative disease of cattle. Transmissible Spongiform Encephalopathies (TSE), also known as prion diseases, are a family of diseases, occurring in humans and animals and are characterized by a degeneration of brain tissue giving a sponge-like appearance leading to death.
This certificate declares that the product is free from animal-derived materials including bovine products.
What does GMO (Genetically Modified Organisms) mean?
Genetically Modified Organisms (GMO), are living organisms and their genetic material has been artificially manipulated in a laboratory through genetic engineering. This creates combinations of plant-, animal-, bacteria-, and virus genes that do not occur in nature or through traditional breeding methods. Livestock and crops are the most common GMO’s today, for example, livestock will be bred to develop more muscle or fat and crops to grow larger and faster
Pharmaceutical and chemical companies that manufacture Non-GMO raw materials, are required to have a statement ensuring the validity of all Non-GMO raw materials.
What is a WC? (Written Confirmation)
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “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 a WC. 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.
Japan, the United States, Brazil, Australia, Israel, Switzerland and South Korea are the countries that have currently been granted exemption from a Written Confirmation, and there are a couple of more countries who have applied. The list of these countries can be found on the website of the European Commission.
What is GDP? (Good Distribution Practice)
GDP is a quality system for warehouses and distribution centers dedicated to pharmaceutical products. 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 to a system.
These are just a few of the certificates present in the pharmaceutical industry, but they are the ones we found most relevant and are those that are listed on the product pages here on Pharmaoffer.
Ammar Badwy | Posted on October 14, 2022
I have written this blog to the best of my knowledge and belief. I’m not a pharmacist and don’t bear the responsibility for any errors or mistakes.
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