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OCABR Human Biologicals
2007 Product Specific Guidelines and Procedures
(03/09/08) The guidelines and procedures for OCABR are now available to download.
NEW: In force from 1st October 2008
- A NEW guideline for Cell Cultured Influenza Vaccine (surface antigen, inactivated)
- Revision of the following guidelines to maintain consistency with other influenza guidelines in particular to streamline submissions of information on starting materials and to harmonising presentation on inactivation:
- Influenza Vaccine
- Pandemic Influenza Vaccine
- Influenza Vaccine (surface antigen, inactivated virosome)
- Revision of the guideline for Rabies Vaccine to allow changes in tests by OMCLs according to new revisions in specific Marketing Authorisations
- Revision of the EC Administrative Procedure for Official Control Authority Batch Release to update Annex IIf and to include a new Annex VIII
For more information, please click HERE.
Quality Assurance
(01/07/08) A new annex of the OMCL Network guideline 'Qualification of equipment' was adopted at the OMCL annual meeting held in June 2008. Annex 5: Qualification of Automatic Titrators, can be found under our Quality Assurance Actvities Guidelines section.
OMCL Annual Seminar 2008
(20/06/08) The EDQM held its 13th Annual Meeting of the Official Medicines Control Laboratory (OMCL) Network in Strasbourg from 2 to 6 June 2008. This annual conference was organised at the new headquarters of the EDQM and was attended by over 200 participants. More information...
The list of Proficiency Testing Studies (PTS) for 2008
An European programme open to OMCLs and other medicine control laboratories. More information
OMCL Annual Seminar
OMCL Annual Seminar, 2-6 June 2008 13th Annual Meeting of European Network of Official Medicines Control Laboratories (OMCL), Strasbourg, France, 2-6 June 2008
The EU/EAA Network for Official Control Authority Batch Release of Biologicals for Human Use, The Regulatory Affairs Journal, June 2002
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