TheInternational Pharmacopoeia is a collection of recommended procedures for analysis and specifications for active pharmaceutical ingredients, excipients and finished pharmaceutical products. It serves WHO Member States wishing to establish pharmaceutical requirements as source material for reference or adaptation.
The International Pharmacopoeia focuses on monographs of particular relevance to low- and middle-income countries which may not have sufficient resources to develop national pharmacopoeias. Our compendium supports key WHO activities, such as the Organization's efforts to make essential medicines available and affordable for everyone, everywhere and to combat substandard and falsified medicines.
The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization[1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms,[2] together with supporting general methods of analysis, for global use. Its texts can be used or adapted by any WHO member state wishing to establish legal pharmaceutical requirements.[2]
The Ph.Int. is designed to serve all Member States, especially their national and regional regulatory authorities, organizations in the United Nations system, and regional and interregional harmonization efforts, and they underpin important public health initiatives, including the prequalification and procurement of quality medicines through major international entities, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNICEF.
The monographs published in the Ph.Int. are established in an independent manner via a consultative procedure and based on international experience.[3]Monographs on radiopharmaceuticals developed with the International Atomic Energy Agency.
The International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances (active pharmaceutical ingredients, APIs) and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. The Ph. Int. has legal status, whenever a national or regional authority refers to it in appropriate legislation.
Compared to other pharmacopoeias (e.g. Ph. Eur., USP, JP), "priority is given to medicines included in the WHO Model List of Essential Medicines and to medicines which are important for WHO health programmes and for which other pharmacopoeias do not offer any test specifications". Moreover, the needs of developing countries are taken into account.
The International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. The Ph. Int. is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation.
It is emphasized that pharmacopoeial specifications represent only one element of quality assurance. Pharmaceutical substances and dosage forms should be manufactured according to the current GMP requirements (GMP = Good Manufacturing Practices). In many cases, this compliance cannot be verified by only analyzing a sample of the final product against a pharmacopoeial monograph. The national, regional or other competent authority will need to ensure that all relevant provisions have been met (e.g. by GMP inspection of the manufacturing sites or testing of samples beyond specifications).
The Expert Committee on the Unification of Pharmacopeias was created in 1947 to continue the work of the League of Nations' International Commission of Pharmacopoeial Experts, under the aegis of the newly established World Health Organization (WHO). Both USP Committee of Revision Chairman E. Fullerton Cook and later Lloyd Miller, USP Director of Revision served on this committee. In 1951, the first edition of the International Pharmacopoeia was published after nearly a century of international debate. The compendia contained monographs for 200 drugs, and nearly 80 percent of its content originated from the USP or British Pharmacopoeia.
In addition, the International Conference on Biological Standardization continued to meet during this period, and the expansion of USP's Reference Standards program led to increased cooperation in the preparation and distribution of WHO Authentic Chemical Substances.
Concerns that the draft revision of the WHO International Pharmacopoeia would restrict access to medical oxygen are resolved. Past uncertainties caused by separate international definitions of medicinal oxygen dependant on concentration are thus eliminated. Healthcare Authorities, Hospitals and Healthcare Professionals working to the
PH.INT definition can now treat patients with both oxygen 93% and oxygen 99.5% regardless of source.
This new definition comes as a result of in-depth consultation with globally recognized experts on the subject of patient treatment with Medicinal Oxygen. The WHO hereby drew on support from several key organizations including The Every Breath Counts Coalition , The World Federation of Societies of Anesthesiologists WFSA , ISO Technical Committee 121 (Anaesthetic and Respiratory Equipment) and the International Association of Manufacturers of Medical Gas Generators for Hospitals (MEDIGHAM)
Finally, the experts at the WHO are to be congratulated for taking a leading role in reducing barriers to Medicinal Oxygen, especially in Low and Middle Income Countries LMICs. Their fact-based amendment of
PH.INT is both groundbreakingly vital and farsighted. As a direct result, innumerable patients will benefit from increased access to Medicinal Oxygen, alleviating suffering and saving lives throughout the world.
Pharmacopoeia is a collection of standards and guidelines that are used to test the quality, safety, and efficacy of pharmaceuticals, medical devices, and other healthcare products. Pharmacopoeias are essential resources for pharmacists, doctors, and other healthcare professionals to ensure that the medicines they use meet the necessary quality and safety standards. In this paper, we will compare and contrast various international pharmacopoeias, their similarities, and differences. There are several international pharmacopoeias that are widely used across the world. These include the United States Pharmacopeia, European Pharmacopoeia, Japanese Pharmacopoeia, British Pharmacopoeia and the International Pharmacopoeia. All of these pharmacopoeias are published by reputable organizations, which ensure that the standards are of the highest quality.
The United States Pharmacopeia is one of the most widely used pharmacopoeias in the world. It is published by the United States Pharmacopeia Convention, a non-profit organization that sets standards for the quality, purity, and strength of medicines, food ingredients, and dietary supplements. The contains more than 4,000 monographs for drugs, dietary supplements, and excipients. It also provides guidelines for analytical methods, which are used to test the quality of these products. The European Pharmacopoeia is the official pharmacopoeia of the European Union. It is published by the European Directorate for the Quality of Medicines and Healthcare and contains over 2,000 monographs for active substances, excipients, and finished products. The Ph. Eur. is used to ensure that the medicines used in the European Union meet the necessary quality, safety, and efficacy standards. The Ph. Eur. also provides guidelines for analytical methods, which are used to test the quality of these products [1].
The Japanese Pharmacopoeia (JP) is published by the Ministry of Health, Labour and Welfare (MHLW) and contains standards for pharmaceuticals, medical devices, and other healthcare products. The JP contains over 3,000 monographs for drugs, excipients, and medical devices. The JP also provides guidelines for analytical methods, which are used to test the quality of these products [2].
The majority of the United Kingdom. It is published by the Medicines and Healthcare products Regulatory Agency (MHRA) and contains over 4,000 monographs for drugs, excipients, and medical devices. The BP also provides guidelines for analytical methods, which are used to test the quality of these products. The International Pharmacopoeia (IP) is published by the World Health Organization (WHO) and contains standards for pharmaceuticals, medical devices, and other healthcare products. The IP contains over 300 monographs for drugs, excipients, and medical devices. The IP also provides guidelines for analytical methods, which are used to test the quality of these products.
Despite the differences in the number of monographs and guidelines, there are several similarities between these international pharmacopoeias. For instance, all of these pharmacopoeias provide standards for the quality, purity, and strength of medicines, food ingredients, and dietary supplements. They also provide guidelines for analytical methods, which are used to test the quality of these products. Additionally, they all strive to ensure that the medicines used in their respective regions meet the necessary quality, safety, and efficacy standards. However, there are also some differences between these pharmacopoeias. One of the main differences is the number of monographs that each pharmacopoeia contains. For example, the USP contains more than 4,000 monographs, while the IP contains only 300 monographs. The Ph. Eur. and the BP contain over 2,000 and 4,000 monographs, respectively. Another difference is the focus of each pharmacopoeia. For instance, the JP places a greater emphasis on traditional Japanese medicines, while the USP focuses on drugs, dietary supplements, and excipients that are used in the United States [3].
3a8082e126