farmakopeia

Farmakopeia, or pharmacopoeia in English, is an official publication that codifies the quality standards for medicines and their substances. It provides legally binding monographs with specifications for active pharmaceutical ingredients, dosage forms, excipients, and labeling, as well as the analytical methods to verify identity, strength, purity, and quality. Pharmacopoeias can be national, regional, or international and are used by regulators, manufacturers, and quality-control laboratories.

A pharmacopoeia typically contains monographs for drugs and other substances, general chapters on sampling and testing, reference standards, storage conditions, and packaging and labeling requirements. It also prescribes methods for key analyses such as identity tests, assay, impurity profiling, dissolution testing, and microbiological criteria. The aim is to ensure consistency, safety, and efficacy across medicines and products.

History and examples frame the pharmacopoeia as a product of evolving regulatory needs. Early modern Europe saw the emergence of official pharmacopoeias, such as the Pharmacopoeia Londinensis in the 17th century. Today, major examples include the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopoeia (USP), the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP). The World Health Organization publishes the International Pharmacopoeia to support harmonization and guidance for national standards.

Regulatory role and impact are central to pharmacopoeias. They provide the standards used for product licensing, quality-control testing, and pharmacovigilance. Compliance helps ensure medicine quality, facilitates international trade, and supports regulatory consistency, while deviations can trigger recalls or regulatory actions. Harmonization efforts continue through international collaborations and regional authorities.

In Poland, the Polska Farmakopea serves as the national pharmacopoeia, providing official standards for medicines and related substances within the Polish regulatory framework.