Biological Standardisation Programme (BSP) - Background & Mission
A contract was signed in 1991 between the Commission of the European Communities and the Council of Europe to allow for the provision of logistical and scientific assistance for activities related to the testing of biological medicinal products (commonly known as biologicals) in particular vaccines and blood.
This contract covers research activities within the Biological Standardisation Programme (BSP) implemented under a Steering Committee. The Secretariat is provided by the Biological Standardisation, OMCL Network and HealthCare Department (DBO) of the EDQM.
The Biological Standardisation Programme is financed by a specific budget contributed by the two contracting parties. The Commission of the European Communities has since officially become a party to the Convention on the Elaboration of a European Pharmacopoeia and has been continuing to make a financial contribution every year. Non-EU countries may also make a financial contribution. To improve international harmonisation, whenever possible, collaborative studies run under the BSP are also co-ordinated with those planned and carried out by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA).
The full reports of the concluded collaborative studies are published in Pharmeuropa Bio & Scientific Notes.
This contract has given new impetus to activities in the biological field by complementing the work performed by the relevant groups of experts of the European Pharmacopoeia Commission.
The mission of the BSP is to:
- elaborate European Pharmacopoeia Reference Standards and working standards for biologicals (i.e. biological reference preparations [BRP] and chemical reference substances [CRS])
- standardisation of test methods for the quality control of biologicals;
- elaborate alternative methods for the quality control of biologicals in order to apply the 3Rs concept (refine, reduce, replace) to use of animals in laboratory experiments
- contribute to the activities of the International Conference on Harmonisation (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) in the field of biologicals.
CombiStats is a computer program for the statistical analysis of data from biological dilution assays or potency assays. The software was developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia.