Pharmacopeia: EP, USP and JP
There are three prime regional Pharmacopoeia organisations that are responsible for the preparation and publication of Pharmacopoeia monographs, covering the commonly used pharmaceutical prescription and over-the-counter medicines, dietary supplements, excipients and other healthcare products manufactured and sold.
The three prime organisations are:
- European Directorate for the Quality of Medicines (EDQM) - responsible for the European Pharmacopeia (Ph Eur) monographs;
- United States Pharmacopeial Convention - responsible for the US Pharmacopoeia (USP);
- Ministry of Health and Welfare - responsible for the Japanese Pharmacopoeia (JP).
APG Pharma offers the widest selection of certified primary packaging products in accordance with United States Pharmacopeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia(JP)
About the European Pharmacopoeia (EP)
The texts of the European Pharmacopoeia (EP, Ph. Eur.) concern the qualitative and quantitative composition of medicines, the tests to be carried out on medicines, on the raw materials used in the production of medicines and on the intermediates of synthesis. It contains texts covering substances, excipients and preparations for pharmaceutical use of chemical, animal, human or herbal origin, homoeopathic preparations and homoeopathic stocks, and antibiotics, as well as dosage forms and containers. The texts also cover biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations. They are legally binding.
About the United States Pharmacopeial Convention (USP)
The United States Pharmacopeial Convention (USP) is a scientific nonprofit organisation that sets standards for the identity, strength, quality, and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. USP drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are developed and relied upon in more than 140 countries. USP standards are recognised in a variety of U.S. federal legislation.
While not a government entity, USP works closely with government agencies, ministries, and regulatory authorities around the world to help provide standards of identity, strength, quality, and purity that can help safeguard the global supply of medicines, dietary supplements, and food ingredients. In the U.S. and various other countries, USP standards are recognized in laws or accepted as a means of meeting certain regulatory criteria. Some international regulatory authorities and governments have incorporated USP standards into their laws and regulatory provisions to help protect the quality of products and ingredients produced in or exported to their countries.
About the Japanese Pharmacopoeia (JP)
The Japanese Pharmacopoeia (JP) is a book of official pharmaceutical standards in Japan, prepared by the JP secretariat in Pharmaceuticals and Medical Devices Agency (PMDA) and established by the Minister of Health, Labour and Welfare (MHLW).
The JP contains the official standards required to assure the quality of medicines in Japan in response to the progress of science and technology and medical demands at the time. It defines the standards for specifications, as well as the methods of testing to assure the overall quality of all drugs, and it plays a role in clarifying the criteria for quality assurance of drugs that are recognised as essential for public health and medical treatment.
The Japanese Pharmacopoeia (JP) is evaluated and reviewed by expert committees in meetings periodically held by the JP secretariat. The JP was first published in June 1886 and implemented in July 1887. The JP has been revised periodically. The 16th edition came into effect in April 2011 under the Ministerial Notification No. 65.