On 16th December 2014, the 5 in 1 Vaccine (Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b) produced by BioFarma has been granted a Pre-qualification (PQ) of the World Health Organization (WHO). Hence this product is added to the vaccines listed by the WHO to be purchased through UNICEF, PAHO and other international agencies and countries in the world
“With the addition of the Pentavalent vaccine, Pentabio, the total of BioFarma’s vaccines that listed in the pre-qualification WHO are as many as 13 products” said Dr. Iskandar, President Director of BioFarma, at the inauguration ceremony of the Administration Building 2 while laying the cornerstone of the new production and packaging facility.
The vaccines produced by BioFarma having WHO PQ since 1997 to the present day are indicated in the picture below.
Iskandar conveyed his gratitude to all employees of BioFarma for their efforts, as the process of obtaining the WHO PQ is not an easy task. This decision is based on the review of the Product Summary File, evaluation on the consistency of the final product, on site audits to the manufacturing facility and the follow up of the implementation of recommendations made by the WHO reviewers during the evaluation. The WHO carries out assessments of the quality, safety and efficacy of vaccines and other products from various sources in the world, if requested by the respective manufacturer. An important aspect of the WHO pre-qualification process includes the commitment of management, the implementation of a comprehensive quality management system, as well as the involvement of the respective National Regulatory Agency.
Adapted from News Biofarma, Press Release available at http://www.biofarma.co.id/?p=18041&lang=en