Farmakopeer

Farmakopeer is a term used in pharmaceutical regulation and pharmacopoeial practice to denote a group of experts who conduct peer review of pharmacopoeial standards and related quality control methods. The concept combines “farmako-” (pharmacopoeia or drugs) with “peer,” signaling an independent, professional assessment by colleagues rather than a single authority.

Role and functions: Farmakopeers provide evaluation and critique of proposed monographs, analytical methods, reference standards, and impurity profiles. They assess method validation, accuracy, precision, robustness, and suitability for regulatory use. They help ensure that pharmacopoeial requirements reflect the latest science and international consensus.

Organization and process: In jurisdictions where the term is used, farmakopeers may serve on a standing committee or as temporary expert reviewers attached to a pharmacopoeia authority or professional association. Proposals for new or revised monographs are circulated to farmakopeers for comment, followed by revision, public consultation, and publication.

Impact: The work of farmakopeers supports quality assurance in medicines, bioequivalence testing, and regulatory compliance. It helps harmonize standards across national pharmacopoeias and aligns with international guidelines.

History and usage: The exact structure and duties of a farmakopeer can vary by country or organization, and the term is not universally standardized. In some languages the equivalent term may be used to describe a peer-review group within pharmacopoeial committees or regulatory bodies.

See also: Pharmacopoeia, expert committee, regulatory affairs, quality control, analytical chemistry.