Bio Farma Mulai Ekspor Pentabio

BANDUNG,­ PT Bio Farma tahun ini mulai membidik pasar ekspor untuk produk vaksin Pentabio, setelah pada 16 Desember tahun lalu produk vaksin terbaru itu lulus prakualifikasi (PQ) dari Badan Kesehatan Dunia (World Health Organization). "Lolosnya produk Pentabio menambah portofolio vaksin Bio Farma yang listed untuk dibeli oleh Badan Keseha­tan Dunia (WHO), UNICEF, PAHO, serta negara-­negara lain di dunia, selain tentunya memprioritaskan kebutuhan pasar dalam negeri. Dengan penambahan produk vaksin Pentabio, total produk vaksin Bio Farma yang listed di WHO menjadi sebanyak 13 produk," ujar Nurlela, Kepala Humas PT Bio Farma, Kamis (8/1). Menurutnya, Lembaga kesehatan dunia atau WHO memiliki kewenangan untuk menilai kualitas, keamanan, dan khasiat produk vaksin dari berbagai produsen dunia. Prakualifikasi WHO dilakukan untuk menilai kualitas vaksin, memenuhi spesifikasi tender, dan memenuhi standar mutu. Aspek penting dalam prakualifikasi WHO mencakup komitmen manajemen, penerapan quality management system secara menyeluruh, serta kualitas badan POM di ne­gara tersebut. "Keputusan ini didasarkan pada review product summary file, evaluasi dari konsistensi karakteristik produk ak­hir, audit visitasi ke fasilitas produksi, dan menindaklanjuti pelaksanaan rekomendasi yang dibuat oleh reviewer WHO selama evaluasi." Nurlela menyatakan sedang membidik sejumlah negara untuk ekspor Pentabio, khususnya negara-­negara berkembang yang selama ini melakukan Kerja sama pengembangan vaksin. "Untuk ekspor Pentabio, kami baru akan mengikuti ten­der­tender internasional," tegasnya. Sementara itu, untuk penggunaan lokal, saat ini Pentabio telah digunakan di empat provinsi yakni Jawa Barat, Bali, Yogyakarta, dan Nusa Tenggara Barat. Tahun ini diha­rapkan seluruh provinsi sudah dapat menggunakan Pent­abio. ■ tgh/E­9 Sumber : Koran Jakarta

BANDUNG,­ this year PT Bio Farma started to target export market for Pentabio vaccine products after on 16 December last year, this latest vaccine products passed the prequalification (PQ) stage of the World Health Organization. “The success of Pentabio product has added the portfolio of Bio Farma’s vaccines which are listed to be purchased by the World Health Organization (WHO), UNICEF, PAHO, and other countries in the world, besides indeed prioritizing domestic needs. By adding the Pentabio vaccine products, the total vaccine products of Bio Farma which are listed in WHO is 13 products,” as explained by Nurlela, the Head of Corporate Communication of PT Bio Farma, Thursday (8/1) According to her, the world health institution or WHO has the authority to evaluate the quality, safety, and efficacy of vaccine products from all global manufacturers. WHO’s prequalification stage is conducted to evaluate the vaccine quality, fulfill the tender specification, and meet the quality standard. The important aspects of WHO’s prequalification stage include the management commitment, the comprehensive implementation of quality management system, and the quality of Food and Drugs Supervisory Agency (BPOM) in that country.” “The decision is based on the product review, summary file, evaluation of the consistency of the final product characteristics, audit of the product facility visit, and follow up of the recommendation implementation made by the WHO reviewers during the evaluation.” Nurlela stated that the company is targeting on several countries to export the Pentabio products, especially developing countries which are cooperating in developing the vaccines for these times. “For the export of Pentabio, we will participate in international tender,” she said. Meanwhile, for local use, currently Pentabio has been used in four provinces, which are West Java, Bali, Yogyakarta, and Nusa Tenggara Barat. This year, it is expected that all provinces will use the Pentabio products. ■ tgh/E­9 Source : Koran Jakarta