Pharmacopoeial standards
Pharmacopoeial standards provide a common technical basis for evaluating the quality of medicines. They belong to the quality-assurance side of pharmacy and should not be confused with clinical evidence that a medicine benefits a particular patient.
In a 2021 historical review, Oleksandr Gryzodub describes the development of the State Pharmacopoeia of Ukraine during its first twenty years. The discussion connects harmonization with the European Pharmacopoeia, national requirements, reference standards and proficiency testing for laboratories. These elements show that a pharmacopoeia is supported by testing infrastructure, not simply by publication of a standards book.
The article is a historical account of the system as described in 2021. Current compliance decisions require the applicable pharmacopoeial edition and current regulatory requirements. Related topics: pharmaceutical quality, reference standards, laboratory proficiency testing and pharmaceutical law.
Source
Gryzodub, O. (2021). Twenty Years of The State Pharmacopoeia of Ukraine: The Experience of Establishing the First National Pharmacopoeia in The Post-Soviet Area. SSP Modern Pharmacy and Medicine, 1(2), 1–20.
See also: Terms and concepts index · Journal research map · History and research foundations.