In pursuit of a global compendium for medicinal products.
A naïve ideal or an ideal pharmacopoeia?
When I started working in a major pharmaceutical company over thirty years ago my senior manager pointed to the Red Book (the USP) as my optimal guide. How correct he was! Ever since I turned to the book for general notices, general requirements, analytical methods, specifications for raw material, finished products, and information at large. Today, the importance of compendia in the global business is much more relevant than thirty years ago, since specifications for registration and operations are well anchored to the regions where the medicinal products are marketed. Accordingly, one must track and know all the major pharmacopoeias in all continents. Sounds easy, right? But what happens when the requirements are not the same or, worse, are similar yet somewhat different? And how would one apply them during R&D, either at the exploratory stage or in pharmaceutical development in particular, when the medicinal product is being investigated and the markets have not yet been identified? These are indeed implementation issues to be reckoned with by scientists working in various disciplines, R&D, technical operations and in regulatory functions.
It is in this area that the harmonization of compendia requirements across various pharmacopoeias comes to the rescue. Much harmonization has already been done by the Pharmaceutical Discussion Group-International Conference on Harmonization (PDG-ICH), a group of experts across the US, Europe and Japan with participation of the respective pharmacopoeias. However, much more is needed, especially to cover those gaps still existing in some “harmonized” requirements, and for those new ones that are just entering the pharmacopoeia worlds.
One wish of many colleagues is that global compendial standards be established, adopted in the industry and accepted by regulators (reference), as the broad infrastructure and network of common reference. Let only the languages, formats, and wording vary according to the established legacy compendia, while keeping the content globally fully harmonized. Moreover, the same concept ought to apply to reference standards used by industry and regulators to make measurements in their analytical methods. Is it too much to ask to foster a global pharmacopoeia with real commitment by all parties?
Successful steps have already been taken toward this goal. Solid achievements have already been attained. Examples include:
a. the coalescence of the national pharmacopoeias of Europe into the current Ph. Eur., with numerous member states and countries with observer status;
b. the PDG-ICH process that has already bridged several general requirements and individual compendial monographs for drug substances and excipients;
c. current efforts for prospective harmonization;
d. mutual acceptance by regulators of public standards in the USP, Ph. Eur. And JP.
However, much remains to be done to achieve synergy between the pharmacopoeias and the regulators, the objective being facilitating the registration of medicinal products. In this area industry plays a big role as, along with regulators, it is the main user of and is greatly impacted by compendial standards. One should feel encouraged that a clear vision exists and some concrete steps have already been taken toward the path to a global compendium or ideal pharmacopoeia. It is the truly ideal state that is worth pursuing in today’s global economy, keeping in mind that the ultimate beneficiary is the patient who uses the medicinal products with the assurance that global quality standards sustain suppliers, manufacturers and regulators.
Reference: Compendial Issues: A Position Paper on the Ideal Pharmacopoeia; J. Mark Wiggins et al.; Pharmaceutical Technology, 32(11), pp 122-125; November 2, 2008.