• Aller au contenu
• Aller à la navigation
• Aller à la recherche

Passer les liens principaux

• 
  • What's new?
  • Vision, Mission & Values
  • History
  • Structure
  • Quality, Safety & Environment
  • EDQM Library
  • Visit the EDQM
  • Contact the EDQM
• 
  • News and General Information
  • Blood Transfusion
    • Background & Mission
    • Organisation & Work Programme
    • Reports
    • Recommendations & Resolutions
    • Projects
    • World Blood Donor Day
  • Organ Transplantation
    • Background & Mission
    • Organisation & Work Programme
    • Reports
    • Recommendations & Resolutions
    • Projects
    • European Day for Organ Donation and Transplantation
  • Pharmaceutical Care
    • Pharmaceuticals & Pharmaceutical Care
    • Classification of Medicines as Regards their Supply
    • Quality and Safety Standards in Pharmaceutical Practices & Pharmaceutical Care
    • How to Minimise Public Health Risks Posed by Counterfeiting of Medical Products & Similar Crimes
  • Anti-counterfeiting activities
    • eTACT
    • The Medicrime Convention
• 
  • News and General Information
  • European Pharmacopoeia
    • Background & Legal Framework
    • Mission
    • Membership & Observership
    • Elaborations & Revisions
    • Participate in the Work of the Ph. Eur.
    • Work Programme
    • International Harmonisation
  • Reference Standards
    • Ph. Eur. Reference Standards
    • WHO International Standards for Antibiotics (ISA)
    • WHO International Chemical Reference Substances (ICRS)
  • Biological Standardisation Programme (BSP)
    • Background & Mission
    • The Steering Committee
    • Participate in a BSP Study
    • Work Programme
• 
  • News and General Information
  • General European OMCL Network
  • Gene Therapy
  • Proficiency Testing Scheme (PTS)
  • Quality Management (QM) Programme
  • Market Surveillance Studies (MSS)
  • Human Biologicals (OCABR)
  • Veterinary Biologicals (OCABR/OBPR)
  • CAP Sampling & Testing Programme
  • MRP/DCP Post Marketing Surveillance Scheme
  • Quality Monitoring of Stockpiled Medicines
  • Testing of counterfeit / illegal medicines within the GEON
• 
  • News and General Information
  • Background & Legal Framework
  • Mission & Organisation
  • New Applications
  • Revisions & Renewals
  • Technical Advice & One-to-One Meetings
  • The Inspection Programme
• 
  • Publications
    • European Pharmacopoeia
    • Pharmeuropa, Pharmeuropa Bio & Scientific Notes
    • Standard Terms
    • Blood Transfusion & Organ Transplantation Guides
    • Proceedings of International Conferences
    • Technical Guides
    • Product Specific Guidelines / Model Protocol Templates (OCABR/OBPR)
    • Quality Management (QM) Guidelines
  • Reference Standards
    • EDQM Reference Standards
    • WHO International Standards for Antibiotics (ISA)
    • WHO International Chemical Reference Substances (ICRS)
  • CombiStats
  • Proficiency Testing Scheme (PTS)
  • Certificates of Suitability

Aller aux liens principaux

Homepage / The European Pharmacopoeia / Biological Standardisation Programme (BSP) / Work Programme

Work Programme

Projects in 2011

Vaccines for Human and Veterinary Use

• Validation of a serological potency assay for whole cell pertussis vaccines
• Validation of an in vitro assay for hepatitis A vaccines
• Validation of an alternative test method for human rabies vaccines
• Establishment of the Poliomyelitis vaccine (oral) BRP replacement batch

Plasma-Derived Products

• Chromogenic assay for human coagulation factor VIII
• Establishment of the hepatitis A virus RNA for NAT BRP
• Establishment of the Hepatitis B immunoglobulin BRP

Biotechnology Products

• Establishment of the Erythropoietin CRS
• Establishment of the Somatropin CRS batches 3 and 4
• Calibration of the Heparin sodium BRP for chromogenic assays
• Establishment of BRPs and ELISA assays for two major recombinant allergens (Bet v 1, Phl p 5a)

• Calibration of the Endotoxin BRP batch 5

Adopted BRP/CRS Batches

The studies led to the adoption of the following reference preparations by the European Pharmacopoeia Commission in 2011:

• Tetanus vaccine (adsorbed) BRP batch 3
• Human immunoglobulin BRP for ACA and HPLC batch 1
• Human immunoglobulin BRP for Fc function and HPLC batches 1 and 2
• Human coagulation factors V, VIII, XI and XIII in normal plasma BRP batches 1 and 2