Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. This fundamental principle is an important consideration for the global bio/pharmaceutical industry, including innovator, generic, virtual, and startup companies who wish to develop, manufacture, and market drug products, biotherapeutic products, and vaccines. However, there are many challenges – both external and internal to a company – that make pharmacopoeia compliance difficult.