What are Drug GMP, DMF, FDA, and CEP certifications?

What is GMP? (Good Manufacturing Practice)

GMP stands for Good Manufacturing Practice, defined as "a production system that guarantees the repeatability of product quality to set specifications." Essentially, this means being able to consistently produce products with specific specifications and record all steps in this process.

Without such a system, it would be impossible to determine if an API or drug is produced according to the quality standards set by the industry. This is why the GMP system was introduced, and it has now become a major standard in the global pharmaceutical industry.

Good Manufacturing Practices Different types of GMP / GMP is also known as: cGMP (Current GMP) Current GMP means that the company complies with the latest GMP requirements/versions. WHO GMP (World Health Organization GMP) WHO has its own GMP guidelines. More than 100 countries have incorporated WHO GMP regulations into their national drug laws, and more countries adopt its regulations and methods to define their own GMP requirements.

Local/EU/US GMP: Like WHO GMP, it specifies the agencies auditing the company. For example, to understand the difference between a Chinese GMP certificate and an EU GMP certificate, you must check the difference in GMP requirements of the two authoritative bodies.

What is the 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 federal executive departments of the USA.

The FDA is important because it aims to have companies produce their products according to certain standards, and it uses the FDA certificate to clearly outline this fact. When a company obtains (U.S.) FDA approval, it indicates that the U.S. government has declared the API or drug to be safe and can be sold, imported, or used in the United States.

The U.S. is not the only country to have a regulatory body like the FDA. Most other countries/regions have agencies responsible for the national safety of drugs.

Some different types of organizations include: EMA (European Medicines Agency, EU) MHRA (Medicines and Healthcare products Regulatory Agency, UK) PMDA (Pharmaceuticals and Medical Devices Agency, Japan) CDSCO (Central Drugs Standard Control Organization, India)

What is DMF?

(Drug Master File) A Drug Master File is a document submitted to government agencies containing all the details of the API or drug manufacturing process. This includes information on the chemical properties of the API, the facilities used, the processes used, packaging, storage, etc. To protect the manufacturer's intellectual property, this document is confidential.

Different countries may have different guidelines, which is why there are different types of DMFs. For example, you might have a U.S. DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, etc.

What is ISO?

(International Organization for Standardization) ISO is the International Organization for Standardization. This organization promotes proprietary, industrial, and commercial standards globally. Organizations use the standard to prove their ability to consistently provide products and services that meet customer and regulatory requirements. The ISO system focuses more on corporate management, setting multiple reporting cycles within the company to ensure attention to issues.

Different types of ISO: ISO 9001:2015 (is the standard that specifies requirements for a quality management system)

ISO 14001:2015 (is a standard focused on managing environmental responsibilities)

ISO 22000:2018 (is a standard for a specific industry, describing the specific processes for developing a food safety management system)

ISO 45001:2018 (is a new standard released in March 2018, focused on occupational health and safety. It is based on and will replace the OHSAS 18001 standard between 2018 and 2021)

What is CoA?

(Certificate of Analysis) CoA is a document issued by a company's QA/QC department to confirm that a product meets its product specifications and is part of the quality control of a product batch. CoA usually contains results from laboratory tests of individual batch products. Products can be tested according to different international standards, such as:

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)

Often, there is a lot of overlap between different qualities of a certain API. Certain limit values might vary according to the specific values set by different standards. Different monographs also might mean different testing methods?

Technical data sheets differ from CoA (Certificate of Analysis) because they only contain general product specifications, not the specific batch results that CoA does.

What is MSDS?

(Material Safety Data Sheet) A Material Safety Data Sheet (MSDS) is a product-specific document intended as a reference for the safe use, handling, and processing of products. It includes identifiers, chemical properties, health hazards, precautionary statements, and other relevant information for professionals associated with the product.

Internationally, there are different requirements for MSDS, with MSDS issued in the United States differing from those issued in China. However, in recent years, more and more companies have been updating their MSDS to the GHS system (Globally Harmonized System of Classification and Labelling of Chemicals). GHS is a standard managed by the United Nations (UN), setting a certain structure for SDS (Safety Data Sheets) with 16 sections, general descriptions of health hazards, common symbols, signal words, etc.

MSDS is also known as: SDS (Safety Data Sheet) PSDS (Product Safety Data Sheet)

What is CEP?

(Certificate of Suitability) CEP (also known as Certificate of Suitability to the monographs of the European Pharmacopoeia) is a certificate proving that an API complies with the relevant monographs of the European Pharmacopoeia. It links the monographs in Ph.Eur to the API itself. As part of the market authorization process, the manufacturer of the API submits a CEP, becoming the holder of the document.

As a European certificate, the CEP is granted by EDQM, but recognized by other countries or bodies like the U.S. FDA. Moreover, like DMF, the data submitted in a CEP is strictly confidential and provides a centralized system recognized by many countries.

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