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Indonesia's Agency for Food and Drug Control (BPOM) Holds Workshop on Vaccine Quality Management


June 17, 2013 - Bandung

Indonesia's Agency for Food and Drug Control (BPOM) is to hold a workshop on the quality management for vaccine making of which it has good experience to share with member states of the Organization of Islamic Conference (OIC).

The workshop is to be held on 17 June 2013 alongside the on-going 2nd meeting of vaccine- and medicine-manufacturers of OIC member states in the city of Bandung, West Java province. Delegates and experts from nine 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.

The BPOM workshop is aimed sharing Indonesian experience with other OIC member states on strengthening National Regulation Authority (NRA)'s function in vaccine manufacturing for global markets. 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.

The workshop will start with keynote remarks by BPOM head Lucky S. Slamet, said workshop organizers. Bio Farma will take part in the workshop and share the experiences that the 123-year old vaccine making company has, organizers said.

Bio Farma Sales & Marketing Director Dr. Mahendra Suhardono is scheduled to speak on quality management system (Manufacture, Pre Qualification of Vaccine) in a way to meeting the GMP as set out by the WHO for its prequalification so that the vaccine products are exportable.

Dr. Suhardono is expected to speak about how Bio Farma has been able to maintain an integrated system of quality control management and 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, so that the company can supply its products to over 120 countries worldwide.

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 environmently 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 and PAHO. The company has obtained the Best Export Performance from the Indonesian Trade Ministry consecutively in 2010,2011, 2012 as evidence of its consistent exceptional performance.

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 www.biofarma.co.id.

Source: PT Bio Farma (Persero)

Contact:

M. Rahman Rustan
Corporate Secretary
Bio Farma
+62 22 2033755
+62 22 2041306
pr@biofarma.co.id





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