7 Desember 2015 | (Bandung, 30th December 2014) On 16th December 2014, the 5 in 1 Product of Pentabio Vaccine (Diphtheria, Tetanus, Pertusis, Hepatitis B, Haemophilus influanzae type b) have passed Pre qualification (PQ) of the World Health Organization hence these products are added to the vaccine portfolio of Bio Farma that are listed to be purchased by the World Health Organization (WHO), UNICEF, PAHO and other countries in the world, in addition to prioritizing the needs of the domestic market. This information was conveyed by Iskandar, President Director of Bio Farma in between the inauguration speech of the Administration Building 2 as well as the laying of the cornerstone of the construction of the production and packaging facility, “with the addition of the Pentabio Vaccine product, the Total of Bio Farma’s vaccine products that are listed at WHO are as many as 13 products” Iskandar said.
The World Health Organization (WHO) has the authority to assess the quality, safety and efficacy of the vaccine products from various manufacturers in the world. The WHO prequalification is carried out to assess the quality of the vaccine, whether or not it meets the tender specifications, quality standards. An important aspect in the WHO pre-qualification includes management commitment, the implementation of a comprehensive quality management system, as well as the quality of the National Agency of Food and Drug Control (NADFC or Badan POM) in the country. Iskandar added, that they are very grateful and convey their gratitude for the maximum efforts of all employees of Bio Farma as the process of obtaining the WHO PQ is not an easy task. This decision was based on the review of the Product Summary File, evaluation on the consistency of the characteristics in the final product, visitation audits to the production facility and the follow up of the implementation of recommendation made by the WHO reviewer during the evaluation. The following is the list of vaccines that are PQ from Bio Farma since 1997 to the present day