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40 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series One impor tant fac tor that makes compliance with pharmacopoeia requirements dif f icult is the number of pharmacopoeias that exist and the lack of general harmonization between them. There are as many as 40 pharmacopoeias published around the world, with as many as 60 active pharmacopoeia commissions who carry out the work of developing and maintaining these pharmacopoeias. This global and historical perspective is critical to understanding the par ticular challenges that must be overcome to achieve harmonization among the pharmacopoeias, as well as providing a deeper appreciation of the important harmonization progress achieved to date. In "A Brief History of Pharmacopoeias: A Global Perspective," the authors of this series of articles examine the history and evolution of the pharmacopoeias in more detail, specifically: Early efforts to harmonize pharmacopoeias. In the 19th century, it was recognized that there were inconsistencies in the information contained in the various pharmacopoeias. As a result, there was an emerging focus on efforts to standardize and harmonize the content in the pharmacopoeias. The British Pharmacopoeia (BP) and United States Pharmacopeia (USP) provide early examples of the need for pharmacopoeial harmonization. Historical perspective for other pharmacopoeias. A broader consideration of today's global community reveals a more complex situation with compliance challenges that result from the lack of broad harmonization across the various pharmacopoeias and regulatory agencies around the world. Additional historical examples, including the Chinese Pharmacopoeia (ChP), Indian Pharmacopoeia (IP), Russian Pharmacopoeia (SP RF), and Japanese Pharmacopoeia (JP) bring awareness of the overall timeline for development of the pharmacopoeias and provide the larger global context to the continuing efforts to achieve some degree of compendial harmonization. Creation of a modern, harmonized pharmacopoeia. Pharmacopoeias were initially established to standardize medicines and serve the needs of patients within their respective country. Today, a global view is necessary to meet the needs of global patients. Within this perspective, there is a special place held by the creation of the European Pharmacopoeia (Ph. Eur.), which occurred within the context of modern manufacturing and regulatory systems in Europe and around the world. The Ph. Eur. marks the creation of a single, unified regional pharmacopoeia—it may be argued even an international pharmacopoeia— providing legally binding standards for the quality of medicines and their ingredients in Europe, where previously there had been separate pharmacopoeias in each member country. This represents an important advance in the historical evolution of pharmacopoeias to move toward global standards. Other regional pharmacopoeia initiatives. There have been other efforts to support the harmonization of pharmacopoeia standards between several countries in a particular region, drawing on the successful experience of the Ph. Eur. These include the MERCOSUR pharmacopoeia and the Eurasian Economic Union (EAEU) pharmacopoeia. Toward global pharmacopoeia standards. It is useful to understand the history and specific role played by the International Pharmacopoeia (Ph. Int.) in the global pharmacopoeia landscape. From a compliance perspective, the Ph. Int. only has legal status whenever a national or regional authority expressly introduces it into appropriate legislation. However, the goal of achieving harmonized pharmacopoeia standards for drug quality is deeply rooted in the history of Ph. Int., dating back to 1874. The history of the pharmacopoeias around the world reveals a common purpose to support the health of the population through consistent standards for medicines. Early examples, like the creation of the USP and BP at a national level, as well as later examples, like the Ph. Eur. on a regional level, also show an emphasis on trying to harmonize the quality standards contained in the pharmacopoeias. The history of the Ph. Int. demonstrates that the vision of creating a unified, international pharmacopoeia is not new; the goal of such a pharmacopoeia, which could support public health at a global level goes back nearly 150 years. Click here to read the full article. A BRIEF HISTORY OF PHARMACOPOEIAS: A GLOBAL PERSPECTIVE IQConcept - stock.adobe.com