SERVICEBIOLOGICAL STANDARDIZATION

Mission

The service Biological standardization has a legal activity of quality control for vaccines intended for human use and products derived from blood. It checks the compliance of each batch of these biological medical products by laboratory analyses prior to their placing on the market, independently of manufacturers. 
The service carries out expert activities in these fields, specifically by assessing the "quality" part of registration files, participating in Good Manufacturing Practices (GMP) inspections and the accreditation of transfusion centres, as well as participating in various opinion groups and drafting regulatory texts on these matters.
The aim of the service is also to carry out research and development activities in these fields, for normative purposes.

Tasks

In order to carry out its mission, the service performs the following tasks:

• Check the compliance of vaccine batches intended for human use and products derived from blood with the international standards in effect prior to their placing on the market; regardless of the manufacturer [Royal Decree of 14 December 2006 ].
  • Quality control of vaccines (inactivated viral vaccines, attenuated viral vaccines and bacterial vaccines) and products derived from blood (albumen, immunoglobuline, fabrics cement kit) through performing laboratory analyses. Analyses are chosen mainly so as to verify the appearance of the medical product, its activity, its identity, and its purity
  • Quality control of plasma pools, used in the production of stable products derived from blood, showing the absence of antibodies combating transmissible viruses (HIV, hepatitis B) and the absence of RNA - the messenger carrying the genetic information encoded in the DNA of the hepatitis C virus)
  • Perform the tests required by the European Official Medicines Control Laboratories (OMCL), in a quality control system (ISO 17025) via the implementation of appropriate, approved methods. Most of the division's tests are accredited by BELAC
  • Ensure transfer of methods and/or development of methods to allow new biological medical products to be controlled or to improve control of vaccines or existing blood derivatives on the market
• Provide expertise in the area of vaccines for human use and blood products
  • Assess the "quality" component of registration files, particularly data relating to the medical product's development, its manufacturing and quality control procedure provided by vaccine and blood derivatives producers with a view to obtaining an authorisation for market placing and preparing a report, at the request of the Federal Agency for Medicine and Health Products (AFMPS-FAGG). 
  • As a technical expert, participate in Good Manufacturing Practices (GMP) inspections and transfusion centre accreditation
  • Participate in the writing of scientific opinions and regulatory papers and guidelines, both in a Belgian and an international context, such as opinions of the Superior Health Council, European Pharmacopoeiamonographs, guidance of European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Medecines Agency (EMA), recommendations of the World Health Organisation (WHO) 
  • As a technical expert, participate in audits organised by EDQM and assessments by national regulatory authorities organised by the WHO
• Carry out research and development activities in the field of vaccine quality for human use and blood products

Forms of collaboration

The main partners of the service Biological standardization are: the European Directorate for the Quality of Medicines & Healthcare (EDQM) which coordinates the standardisation, regulation and quality control of vaccine batches and products derived from blood at a European level; the Federal Agency for Medicine and Health Products (AFMPS-FAGG), on whose behalf the service takes part in Good Manufacturing Practices inspections, accreditation of transfusion centres and assessment of quality data for registration files; the European Medicines Agency (EMA) through our participation in various working groups (Biologics Working Party, Vaccine Working Party) and the WHO, on whose behalf the division carries out tests and participates in the pre-qualification procedure for vaccines intended for the United Nations Children's Fund (UNICEF).