Indonesia Shares Experience on Vaccine Quality Management with OIC Members
The Indonesian government has shared experiences with member states of Organization of Islamic Conference (OIC) in strengthening their national regulatory authority (NRA) functions in vaccine manufacturing for global markets.
"We are willing to share with all member states of OIC our experiences in strengthening national regulatory authority functions in vaccine manufacturing," said Lucky S. Slamet, head of Indonesian Agency for Food and Drug Control (BPOM), in a workshop held in conjuction with the 2nd meeting of OIC vaccine- and medicine-manufacturers in Bandung, West Java province, on Monday.
Delegates and experts from nine OIC countries that already have their vaccine making facilities out of the total 57 OIC member countries are attending the meeting which runs from 16 to 19 June, 2013.
In the workshop, Slamet told the workshop that NRAs hold a decisive role in guarranteeing the quality of vaccine supplied to the global markets. The World Health Organization (WHO), therefore, always evaluates the NRAs through capacity building efforts so as to ever strengthen them.
"The WHO has declared us, the Indonesian National Agency of Food and Drug Control, to have performed an internatonal standard control function, in particular, on vaccine. With this achievement, Indonesia now has a wide opportunity - through Bio Farma - to export its products to international markets," she pointed out.
Based on this experience, Slamet added, Indonesia is ready and willing to share with OIC member states the experience in strengthening their RNA functions in vaccine manufacturing.
"Out of the total 57 OIC member states only five countries having their vaccine manufacturers and out of this five only one that can export its products, namely Bio Farma," Slamet emphasized.
According to World Health Organization (WHO), NRAs are national regulatory agencies responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines) are evaluated properly and meet international standards of quality and safety.
Countries producing vaccines need to exercise six critical control functions, and exercise them in a competent and independent manner, backed up with enforcement power. The six functions are a published set of requirements for licensing, surveillance of vaccine field performance, system of lot release, use of laboratory when needed, regular inspections for good manufacturing practices (GMP) and clinical performance evaluation.
Bio Farma Sales and Marketing Director Dr. Mahendra Suhardono also spoke in the workshop on quality management system (Manufacture, Pre Qualification of Vaccine) in a way to meeting the Good Manufacturing Practices (GMP as set out by the for WHO prequalification.
Bio Farma, he said, has been able to maintain an integrated system of quality control management as well as efforts on keeping it update with latest GMP requirements.
Bio Farma is Indonesia's only vaccine manufacturer whose products have been recognized by WHO since 1997 that the company can supply its products to over 120 countries.
Currently the needs for Expanded Program on Immunization (EPI) vaccines in Indonesia have been supplied solely by Bio Farma by producing and distributing over 1.7 billion doses of vaccine per year to meet the needs of EPI vaccine for national immunization program.
Bio Farma has an outstanding international reputation based on the WHO prequalification for all of its EPI vaccine products and has also implemented green industry and is environment friendly. WHO acknowledges that Bio Farma vaccine products are of high quality, efficacious, and affordable.
Bio Farma products are through the direct distribution or through various agencies such as UNICEF, PAHO. The company has obtained the Best Export Performance from the Indonesian Trade Ministry consecutively in 2010,2011, 2012 as an evidence of its consistent exceptional performance.
About OIC
The Organisation of Islamic Cooperation (OIC) is the second largest inter-governmental organization after the United Nations which has membership of 57 states spread over four continents. The Organization is the collective voice of the Muslim world and ensuring to safeguard and protect the interests of the Muslim world in the spirit of promoting international peace and harmony among various people of the world.
About PT Bio Farma (Persero)
Since its establishment in 1890, PT Bio Farma (Persero) has been active in supplying high quality vaccines and serum for people. Currently, Bio Farma is among the largest vaccines manufacturers and suppliers in the world. The need for EPI vaccines in Indonesia has been supplied solely by Bio Farma.
Bio Farma has existed for a century and proven its strength and experience world wide. The company has also grown and developed to become a vaccine and serum manufacturer of international reputation. This can be seen from its qualifications and ability to acquire WHO prequalification for all of its EPI Vaccine products. For more information, please visit http://www.biofarma.co.id/.
(source: www.newsmaker.com.au)