This section of the site gives an overview of Pharmacopoeial activity. UK Pharmacopoeial activity is carried out within the Inspection and Enforcement Division of MCA by the Pharmacopoeial Secretariat Group and the BP Laboratory Unit . Pharmacopoeial standards are objective, public standards of quality for medicines and their components. The Pharmacopoeia is an important statutory component 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 British Pharmacopoeia is the Medicines Act 1968. The BP is prepared by the Pharmacopoeial Secretariat working in collaboration with the BP Laboratory and the BP Commission and its technical committees. The BP 2000 was published in May 2000 and came into effect on 1 December 2000.