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www.biopharminternational.com September 2019 BioPharm International eBook 39 Regulatory Sourcebook Pharmacopoeia Compliance Series ias. There is perhaps some merit in this suggestion, as it might also be perceived as embodying a reg- ulatory dimension of compendial interchangeability, which is essen- tial to the ultimate goal of consis- tent requirements for medicines. However, it may also be suggested that the terms "harmonization" and "convergence" in fact have sim- ilar meanings. One definition of "harmonization" is the "process and/or results of adjusting differ- ences or inconsistencies to bring significant features into agreement" (1). The term "convergence" means "moving toward union or unifor- mity" (2). It should be noted in regard to pharmacopoeias that "harmoni- zation" or "convergence" do not necessarily mean "unison" or "iden- tical". Although the availability of completely "identical" compendial standards might be a desired goal to overcome the challenges of non- harmonized standards in the phar- macopoeias, it should be recognized that "identical" standards are prob- ably not achievable for a number of practical reasons. Fundamentally, the standards published in the pharmacopoeias must be available in the languages needed by their users, regardless of the country. Compendial standards that are equivalent or interchangeable in a practical or functional way should be the goal. Any level of harmoni- zation is beneficial and moves in the right direction to help provide medicines with consistent quality to patients around the world. To further enable the develop- ment of consistent standards for medicines, it is proposed to shift the focus away from the process (i.e., ha r monizat ion or conver- gence) and instead emphasize the intended outcome: global phar- m a c o p o e i a s t a nd a r d s . D e t a i l s about ongoing activities to achieve global pharmacopoeia standards will be provided later, but first, it is appropriate to ask why this goal is important. Compliance with differing quality standards across the many pharmacopoeias has long been a challenge. THE NEED FOR GLOBAL PHARMACOPOEIA STANDARDS: MAKING THE CASE The challenge of compliance with the separate, often divergent com- pendial requirements contained in the various pharmacopoeias around the world provides a strong argu- ment to support the need for global pharmacopoeia standards. The ben- efits 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 any- where, without the complication of divergent pharmacopoeia standards. Most importantly, the patient pop- ulation today is global. Ultimately, there is benefit to patients located around the world who can receive medicines with the same quality, evaluated against consistent speci- fications included in all the phar- macopoeias, regardless of where the product or its ingredients were man- ufactured. Compliance with differing quality standards across the many pharma- copoeias has long been a challenge to be addressed by the bio/phar- maceutical industry. The value and benefits of global pharmacopoeia standards to industry and patients have been noted by the differ- ent pharmacopoeia organizations. USP has written, "Harmonization reduces manufacturers' burden of having to perform analytical pro- cedures in different ways, using dif- ferent acceptance criteria, in order to satisfy pharmacopoeial require- ments that vary across regions" (3). The Ph. Eur. notes the practical con- sideration of international trade as it relates to the availability of medi- cines. "Globalisation and expan- sion in international trade present a growing need to develop global quality standards for medicines" (4). For medicines, the standardized test methods and specifications in the pharmacopoeias must "ensure con- sistent 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" (5). It is also noted that a "harmonized regulatory system, with mutual recognition of assess- ment/decision-making by licensing authorities and inspectors, including globally harmonized pharmacopoe- ias, would be beneficial in several ways" (5). Pharmacopoeias can "also play an important role in protecting patients from some of the downsides of globalization, namely adultera- tion and counterfeiting of medi- cines," however the "prevention of drug adulteration or counterfeiting is not achievable by a pharmacopoeia or any other stakeholder alone" (5). Still, it seems evident that global pharmacopoeia standards could help in this objective, providing consis- tent standards of quality for medi- cines to support patients around the world, whereas divergent compendial standards only serve to complicate the situation.