Site audit to be held 7-10 December 2010
As part of the WHO vaccine prequalification process, reassessments are periodically performed on currently prequalified products. Prequalified products are considered acceptable, in principle, for supply through United Nations agencies. The Bulgarian manufacturer BB-NCIPD Ltd. produces a number of vaccines that have been prequalified by WHO (bacille Calmette-Guérin (BCG) and Diphtheria and Tetanus vaccines).
A WHO site audit of Bul Bio - National Center of Infectious and Parasitic Diseases Ltd. (BB-NCIPD Ltd.) will be held 7-10 December 2010 as part of the reassessment of these products.
Representatives of the Bulgarian Drug Agency (BDA) will participate in the audit and a meeting with the BDA will be held to discuss the audit outcome and ongoing information exchange as part of the continued regulatory oversight of these prequalified products.