11/27/2023 0 Comments Pharmaceutical dossier definitionFor example, you may have a US DMF, ASMF (formally known as EDMF), Japanese DMF, Chinese DMF, et cetera. To protect the intellectual property of the manufacturer, this document is confidential.Ĭountries may have different guidance than other countries, so different types of DMF exist. This includes information on the chemical properties of the API, the facilities used, the processes used, details on packaging, storage, et cetera. CDSCO (Central Drugs Standard Control Organization, India)Ī drug master file is a document submitted to governmental bodies that contains all details of the manufacturing process of an API or medicine.PMDA (Pharmaceuticals and Medical Devices Agency, Japan).MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom).EMA (European Medicines Agency, European Union).Some different kinds of organizations include: Most other countries have agencies responsible for the national safety of pharmaceutical products. The USA is not the only country with a regulatory agency like FDA. When a company is (US) FDA approved, it shows the American government has declared the API or medicine safe and can be sold, imported, or used in the United States. 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.į DA is important because it intends to have companies produce their goods to certain standards and presents this fact in a clear overview using FDA certificates. What is FDA ? (Food and Drug Administration) If you are interested in GMP, check out our blog, discussing GMP in detail and the differences between GMP/cGMP. 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. 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.Īs with the WHO GMP, It specifies the authority that has audited the company. WHO GMP (World Health Organization GMP).That’s why the GMP system was introduced and is now the main standard in the pharmaceutical industry worldwide.ĭifferent kinds of GMP / GMP are also known as:Ĭurrent GMP means that the company complies with the most recent requirements/version of GMP. 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. GMP stands for Good Manufacturing Practices and is defined as “a system of manufacturing that guarantees reproducibility of product quality to set specifications.” It means being able to output a product with certain specifications consistently and documenting all steps in the process. What is GMP? (Good Manufacturing Practices)
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