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40 BioPharm International eBook September 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series IDEAL PHARMACOPOEIA AND COMPENDIAL GLOBALIZATION– AN INDUSTRY PERSPECTIVE T he bio/pha r maceut ica l i ndus- try has itself been discussing the benef its of "har monization" in to d ay 's g loba l pha r m acop o e ia env ironment. The pur pose and role of the pharmacopoeias and the global picture were described in previous articles in this series. There are as many as 40 pharma- copoeias published by author i- t i e s a r o u n d t h e w o r l d . T h e pharmacopoeias were established and evolved to ensure the qual- ity of medicines and their ingre- dients for patients in a country or region. Today's global patient population was not necessar ily part of the overall consideration for t he pha r macopoeia s, espe - cially early in their development. As a result, t he standards con- tained in the various pharmaco- poeias were not generally aligned, c r e a t i n g a c h a l l e n g e f o r t h e industry to comply with all the applicable requirements. Having struggled with the challenge of differing compendial standards for many years, disc ussion was initiated between pharmaceutical i ndu st r y r e pr e s e nt at ive s f rom t h e P h a r m a c e u t i c a l R e s e a r c h a nd Ma nu fac t u rers of A mer ica ( P h R M A ) a n d t h e E u r o p e a n F e d e r at io n o f Ph a r m a c e ut ic a l I n d u s t r i e s a n d A s s o c i a t i o n s ( E F PI A) to explore what m ight be described as the "ideal" phar- macopoeia. T he result of these d i s c u s s i o n s w a s a p o s i t i o n paper, published in 2 0 0 8, t hat presents t his indust r y perspec- t ive (6). T he paper stated t hat the ideal pharmacopoeia would provide appropriate standardiza- tion to facilitate drug registration and support regulatory agencies through a single, global compen- dial standard. The ideal pharmacopoeia would provide a single compendial standard that could be used worldwide. Considering each of these points in turn, appropriate standardiza- tion means the pharmacopoeia would focus on the specific con- tent that prov ides the g reatest value to the bio/pharmaceutical industry for the quality control of drugs. Facilitating drug registra- tion would be achieved by simpli- fying the preparation (by industry) and assessment (by regulators) of drug applications using reference to a common standard for gener- ally accepted quality parameters for pharmaceutical products and ingredients. Alignment between the pharmacopoeias and regulators is essential, so the ideal pharma- copoeia would include standards that are consistent with the needs and expectations of reg ulator y authorities. Most importantly, the ideal pharmacopoeia would pro- vide a single compendial standard that could be used worldwide. The industry perspective on the ideal pharmacopoeia provides a model for the future: a long-term goal that could achieve harmonization of compendial standards, further enhancing the role of the phar- macopoeias to support and pro- mote global public health through safe and effective medicines with appropr iate qua l it y to b enef it patients around the world. Another article from industry describes compendial globaliza- tion and achieving harmonization through standardized practices a nd c ol l ab or at ion a mon g t he p h a r m a c o p o e i a s a n d h e a l t h authorities (7). This article dis- c usses the need for "consistent and appropriate quality require- me nt s fo r me d ic i ne s b e c au s e d i s h a r m o n i z e d s t a n d a r d s d o not provide additional value or benefit, but rather increase the cost and complexity of bringing medicines to patients worldwide." The approach to harmonization described as compendial global- ization "provides a basis for the pharmacopoeias to work together in new ways with consistent pro- cesses coupled w ith shar ing of information and work." The three principles that support compen- dial globalization are: • Standardized pharmacopoeial prac t ices, wh ic h est abl ish a consiste nt approac h for t he phar macopoeias to elaborate compendial standards • Pharmacopoeial collaboration, w h i c h e n h a n c e s t h e c o o p e r a t i o n a m o n g t h e p h a r m a c o p o e i a s t o e n a b l e t h e d e v e l o p m e nt , s h a r i n g , and adoption of harmonized compendial standards • Regulatory acceptance, which e n s u r e s t h e p a r t i c i p a t i o n and agreement by reg ulator y a u t h o r i t i e s w i t h t h e h a r m o n i z e d p r o c e s s e s a n d outcomes in t hose cou nt r ies w h e r e t h e p h a r m a c o p o e i a standards apply. The pharmacopoeias and regu- lators around the world, in col- laboration with their stakeholders, have been actively and success- fully working toward the goal of ha r mon i z at ion for qu ite some t ime. T hese ongoing ha r mon i- zation efforts are supported and encouraged by the bio/pharma- ceutical industry.