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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 45 considerations are important because the sheer number of pharmacopoeias and the current lack of broad harmoniza- tion add complexity to a company's processes for compen- dial monitoring and compliance. The ideal pharmacopoeia would provide a single compendial standard that could be used worldwide. A word about "harmonization" The history of pharmacopoeias since the earliest times has re- flected the goal of creating consistent standards for medicines that are used by those who need them. The process of achiev- ing these consistent standards may be described as standard- ization, harmonization, or any of a number of other words that have a similar meaning. Before delving into some of the ongoing activities to achieve consistent compendial standards in today's global environment for medicines, it is prudent to first address potential concerns with the term "harmoniza- tion" itself. Recent discussion has suggested that it may be preferable to shift from using the word "harmonization" to instead use "convergence" in the context of pharmacopoeias. There is perhaps some merit in this suggestion, as it might also be perceived as embodying a regulatory dimension of compendial interchangeability, which is essential to the ulti- mate goal of consistent requirements for medicines. However, it may also be suggested that the terms "harmonization" and "convergence" in fact have similar meanings. One definition of "harmonization" is the "process and/or results of adjust- ing differences or inconsistencies to bring significant features into agreement" (1). The term "convergence" means "moving toward union or uniformity" (2). It should be noted in regard to pharmacopoeias that "har- monization" or "convergence" do not necessarily mean "uni- son" or "identical". Although the availability of completely "identical" compendial standards might be a desired goal to overcome the challenges of non-harmonized standards in the pharmacopoeias, it should be recognized that "identical" standards are probably not achievable for a number of practi- cal reasons. Fundamentally, the standards published in the pharmacopoeias must be available in the languages needed by their users, regardless of the country. Compendial stan- dards that are equivalent or interchangeable in a practical or functional way should be the goal. Any level of harmoniza- tion is beneficial and moves in the right direction to help provide medicines with consistent quality to patients around the world. To further enable the development of consistent standards for medicines, it is proposed to shift the focus away from the process (i.e., harmonization or convergence) and instead emphasize the intended outcome: global pharmacopoeia standards. Details about ongoing activities to achieve global pharmacopoeia standards will be provided later, but first, it is appropriate to ask why this goal is important. The challenge of compliance with the separate compendial requirements around the world provides a strong argument for global pharmacopoeia standards. The need for global pharmacopoeia standards: Making the case The challenge of compliance with the separate, often di- vergent compendial requirements contained in the vari- ous pharmacopoeias around the world provides a strong argument to support the need for global pharmacopoeia standards. The benefits seem obvious in having global pharmacopoeia standards to ensure consistent quality of medicines. Manufacturing and supply-chains for the bio/ pharmaceutical industry today are global. There is benefit to the industry in having consistent standards with which to comply. There is benefit to regulators who can review drug applications and inspect pharmaceutical facilities anywhere, without the complication of divergent pharmacopoeia stan- dards. Most importantly, the patient population today is global. Ultimately, there is benefit to patients located around the world who can receive medicines with the same quality, evaluated against consistent specifications included in all the pharmacopoeias, regardless of where the product or its ingredients were manufactured. Compliance with differing quality standards across the many pharmacopoeias has long been a challenge to be ad- dressed by the bio/pharmaceutical industry. The value and benefits of global pharmacopoeia standards to industry and patients have been noted by the different pharmacopoeia organizations. USP has written, "Harmonization reduces manufacturers' burden of having to perform analytical pro- cedures in different ways, using different acceptance criteria, in order to satisfy pharmacopoeial requirements that vary across regions" (3). The Ph. Eur. notes the practical consid- eration of international trade as it relates to the availability of medicines. "Globalisation and expansion in international trade present a growing need to develop global quality stan- dards for medicines" (4). For medicines, the standardized test methods and specifications in the pharmacopoeias must "ensure consistent product quality, regardless of its source … especially in view of the shift of API production from Europe and the [United States] US to India and China"