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44 BioPharm International eBook March 2020 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series "suitability for use assessment" that could include testing for any pack- aging system that is at risk, with extractables and leachables among the tests that should be conducted. I t i s r e a s o n a b l e t o e x p e c t other pharmacopoeias to update their requirements for contain- ers and packaging. For example, based on recent surveillance, the ChP is expected to publish exist- ing national standards for drug packaging containers (materials), commonly referred to as the YBB st a nd a rd s. Add it iona l ly, t he re is a n i n for ma l work i ng g roup focused on the creation of a new ICH Q3E guideline for the assess- ment and control of extractables and leachables for pharmaceuticals and biologics (39). Timing for the development of this ICH guideline is not currently known, nor is the manner in which it could eventu- ally be incorporated into the phar- macopoeias, but industry should continue to monitor developments in this impactful area. Rapid microbiological testing Rapid microbiological testing is an area where additional harmoniza- tion would facilitate expanded use of the technology. New chapters introduced in the pharmacopoeia are beginning to address this topic, but they are not fully harmonized. There are differences in method validation requirements between general chapters in Ph. Eur. 5.1.6, USP <1223>, and ChP 9201 (40). Differences between the chapters, including the number of replicates needed for a validation test and the amount of an organism to be added for recovery in a test, lead to a problematic situation. The result is that multiple validations must be done by the company try- ing to implement the technology, with little value added to ensuring product quality. Companies utiliz- ing this technology should ensure these topics are included in the compendial monitoring processes to enable possible advocacy and ensure eventual compliance. Rapid microbiological testing is an area where additional harmonization would facilitate expanded use of the technology. PHARMACOPOEIAS AROUND THE WORLD In the past few years, the health authorities in Japan, China, Brazil, Russia, a nd Korea have beg u n requiring a company to perform compliance checks for their regis- tration files versus what is actually being performed. This points to the increasing importance of com- pliance with the national pharma- copoeias in these countries, where gaps will inevitably become evi- dent during this assessment. Before bringing an additional national pharmacopoeia into their moni- toring program, a company must first ensure there is "baseline com- pliance" with the existing require- ments in the pharmacopoeia. This baseline compliance will likely require a cross-functional project to identify any gaps with existing requirements before routine mon- itoring of revisions to the pharma- copoeia can begin. There are several important points to consider (e.g., translations) when trying to consis- tently monitor national pharmaco- poeias (6,7). These considerations also apply when performing gap evaluations for c urrent f ilings, which must include the national pharmacopoeia requirements. China Ch i na is t he la rgest potent ia l healthcare market in the world based on the size of its population. Recent government reforms and a drive to ensure better healthcare for its people make it a country to focus on in the coming years. It is no longer to be considered an emerging market, but rather, will soon join the United States and Europe among the countries/ reg ions where new d r ug prod- uct registrations will occur first. Though this may be a shocking statement to some, the statement is supported by the rate of regu- latory change and the availabil- it y of accelerated processes to bring newer therapies to China sooner, instead of several years after approval in other countries. Included in this change is the ChP and its practices. China joined ICH in 2017 (41) and is currently in the process of adopting and implementing several ICH qual- ity guidance documents (42,43), many of which will have major impact on the phar macopoeia, such as ICH Q3C (residual solvents) and Q3D (elemental impurities). Additionally, with the adoption of ICH M7 and Q3A and B, designa- tion and reporting of impurities in ChP will potentially change. The CPC has also announced its intention to work w ith the World Health Organization "… to jointly establish a pharmaco- poeia exchange mechanism and a multi-national pharmacopoeia comparison information platform to lay the technical foundation for promoting international pharma- copoeia coordination" (44). In the authors' experience, it is evident the CPC is open to science-based com ments f rom mu lt i nat iona l companies and has shown a will- ingness to adopt new concepts. With the ongoing changes in the