What is the difference between GMP, FDA, DMF, ISO, and CEP?
What is GMP (Good Manufacturing Practices)?
GMP stands for Good Manufacturing Practices. It is defined as “a system that ensures reproducibility of product quality following set specifications.” It means that you can consistently produce a product meeting certain specifications and have documented every step of the production process.
It would be impossible to tell if an API or medicine was produced following industry standards without such a system. GMP was created to ensure that the highest quality standards are met in the pharmaceutical industry.
There are many types of GMP/cGMP.
· cGMP [current GMP]
Current GMP is a company that complies with all current requirements/versions of GMP.
· WHO GMP World Health Organization GMP
The WHO governs GMP. Over 100 countries have adopted the WHO GMP guidelines into their national medicine laws. Many more have adopted their provisions and approach to defining their GMP requirements.
· Local/EU/US GMP
The WHO GMP also specifies the auditing authority. To determine the differences between GMP certificates from China and EU-GMP certificates, you need to verify the GMP requirements of each authority.
What is FDA (Food and Drug Administration)?
The Food and Drug Administration, a federal agency of the United States Department of Health and Human Services, is one of the United States federal executive departments.
FDA is an important agency. It is designed to ensure that companies produce their goods according to specific standards. FDA certificates provide a clear overview of this information. FDA approval means that the American government has approved a company so that the API or medicine can be imported or sold in the United States.
The FDA is not the only regulatory agency in the USA. Many other countries also have agencies responsible for ensuring the safety of pharmaceutical products.
There are many types of organizations:
EMA (European Medicines Agency, European Union)
MHRA, United Kingdom (Medicines and Healthcare products Regulatory Agency)
PMDA (Pharmaceuticals and Medical Devices Agency of Japan)
CDSCO, Central Drugs Standard Control Organization of India
What is a DMF? (Drug Master File)?
A drug master file, which is a document that contains all details about the manufacturing process for an API or medicine, is submitted to government bodies. This information includes details about the chemical properties of the API and the facilities used. This document is confidential to protect the manufacturer’s intellectual property.
Different countries may have different guidelines. This is why there are different types of DMF. You may have a DMF in the USA, ASMF (formally known as EDMF), Japanese DMF, or Chinese DMF.
What is ISO (International Organization for Standardization)?
ISO is an international standardization organization. This organization promotes international standards for industrial, commercial, and proprietary technology. Organizations use the standard to show that they can consistently deliver products and services that comply with regulatory and customer requirements. To ensure that issues are addressed, the ISO system places more emphasis on the company’s management and provides a variety of reporting loops.
Different types of ISO:
ISO 9001:2015 (is a document that specifies the requirements for a quality management program)
ISO 14001:2015 (is an international standard that focuses on environmental responsibility management)
ISO22000:2018 (is a sector-specific standard that describes the process of developing a food safety management program)
ISO 45001–2018 is a new standard published in March 2018. It focuses on occupational safety and health. It replaces the OHSAS 18001 standard for the 2018–2021 periods.
What is a COA (Certificate of Analysis)?
A COA is a document issued by the QA/QC department of a company. It confirms that a product conforms to its product specifications and is part of quality control for a product batch. A COA often contains laboratory results from a particular batch of products. A product can be tested using 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)
There will be much overlap among the various qualities of an API. Depending on the standards, specific limit values may differ. Different monographs can also refer to different testing methods.
Technical data sheets are not the same as COAs. They only contain product specifications and do not include batch-specific results like the COA.
(Related — Medical Device Regulatory Changes in 2021)
What is an MSDS? (Material Safety Datasheet)
A Material Safety Data Sheet is a product-specific document intended to reference safe handling, handling, and processing. It includes information like identifiers and chemical properties and precautionary statements for professionals who work with the product.
An MSDS is required to be issued internationally. One MSDS issued in America will have different requirements than one issued in China. More companies have been updating their MSDSs to the GHS system (Globally Harmonized System of Classification and Labelling of Chemicals). GHS is a standard managed by the United Nations (UN). It provides a structure for an MSDS (16 sections), general statements about health hazards, symbols and signal words, etc.
MSDS can also be known as:
SDS Safety Data Sheet
PSDS Product Safety Data Sheet
What is a CEP (Certificate of Suitability)?
A CEP (also called COS) certificate proves that an API qualifies for the appropriate monograph of European Pharmacopoeia. It connects the monograph in Ph. Eur. It links the API. The manufacturer of the API submits a CEP as part of market authorization. They will then become the CEP holder for the document.
The CEP, a European certificate, is issued by the EDQM. It is also recognized by other countries and institutes like the FDA in the USA. The CEP, like the DMF, is confidential and offers a centralized system that many countries can recognize.
More Useful Resources —
Myths about ISO 14971 Certification and Medical Device Risk Management
