British Pharmacopoeia
Pharmacopoeial standards are objective, public standards of quality for medicines and formulated preparations. The Pharmacopoeia is an important statutory element of the overall system for the control of medicines which complements and assists the licensing and inspection processes. All three statutory components complement and support the quality assurance system operated by the manufacturer. Quality underpins both safety and efficacy and quality assurance is a continuous process.
Pharmacopoeial standards are compliance requirements, that is, they provide the means for an independent judgement as to the overall quality of an article. They apply throughout the shelf-life of a product and are used by a wide variety of organisations including suppliers, purchasers, inspectors, medicines regulators and official and independent control laboratories.
The legal basis for the BP is the Medicines Act 1968 as amended. The British Pharmacopoeia Commission is responsible for preparing new editions of the British Pharmacopoeia and the British Pharmacopoeia (Veterinary) and for keeping them up to date. Under Section 100 of the Medicines Act, the British Pharmacopoeia Commission is also responsible for selecting and devising British Approved Names (BANs).
The current edition of the BP is the British Pharmacopoeia 2012, which contains over 3,000 monographs for substances and articles used in the practice of medicine. The latest edition comprises five volumes that are comprehensively indexed and cross-referenced for easy reference.
The BP incorporates monographs of the European Pharmacopoeia.