Certification from the World Health Organization (WHO)

1. Polio virus vaccine (9 April 1997)
2. Measles Vaccine 10 doses & 20 doses (9 April 1997 & 4 September 2006)
3. Uniject Hepatitis B Vaccine (13 May 2004)
4. Oral Polio Vaccine Type 1/mOPV-1 Oral Monovalent Vaccine (3 November 2009)
5. Oral Polio Vaccine/bOPV bivalent vaccine (26 May 2010)
6. Diphtheria, Pertussis, Tetanus Bacterial Vaccines (6 April 2011)
7. Tetanus Vaccine in a vial (March 11, 1999) & Uniject (29 October 2003)
8. Td Vaccine (6 July 2011)
9. DT Vaccine (11 March 1999)
10. DT P-HB Combination Vaccine (7 October 2004)
11. Pentabio Vaccine (16 December 2014)

CPOB Certificate (Good Manufacturing Practices) from the Indonesian Food and Drug Administration (BPOM-RI)

1. Measles Vaccine Bulk (April 25, 2019): SPF Chicken Breeding, Making Bulk. Certification validity period: April 25, 2019
2. 2BCG Vaccine Bulk (April 25, 2019): Preparation of Bulk. Certification validity period: April 25, 2019
3. Diphtheria Toxoid Bulk (April 25, 2019): Cultivation and Detoxification, Purification. Certification validity period: April 25, 2019
4. Bulk Toxoid Tetanus (April 25, 2019): Cultivation and Detoxification, Purification. Certification validity period: April 25, 2019
5. Virus Vaccine (April 25, 2019): Formulation, Filling, Lyophilization of Measles Vaccine; Measles Vaccine Packaging. Certification validity period: April 25, 2019
6. Virus Vaccine (April 25, 2019): Formulation, Filling of Polio Vaccine; Polio Vaccine Packaging. Certification validity period: April 25, 2019
7. Virus Vaccine (25 April 2019): Hepatitis B Vaccine Formulation & Filling; Hepatitis B Vaccine Packaging; Seasonal Flu Vaccine Formulations & Fills; Seasonal Flu Vaccine Packaging; IPV Vaccine Formulation & Filling; IPV Vaccine Packaging. Certification validity period: April 24, 2024
8. Bacterial Vaccine, namely BCG Vaccine (April 25, 2019): Formulation, Filling, Lyophilization; Packaging. Certification validity period: April 25, 2019
9. Bacterial Vaccines (April 25, 2019): Formulation & Filling of DTP Vaccines; DTP Vaccine Packaging; TT Vaccine Formulation & Filling; TT Vaccine Packaging; DT Vaccine Formulation & Filling; DT Vaccine Packaging; Td Vaccine Formulations & Filling; Td Vaccine Packaging; Typhoid Vaccine Formulation & Filling; Typhoid Vaccine Packaging. Certification validity period: April 25, 2019
10. Combination Vaccine (April 25, 2019): Formulation & Filling of DTP-HB Vaccine; DTP-HB Vaccine Packaging; Formulation & Filling of DTP-HB-HiB Vaccine; DTPHB-HiB Vaccine Packaging. Certification validity period: April 25, 2019
11. Solvent Vaccines (April 25, 2019): Filling, Packaging. Certification validity period: April 25, 2019
12. Polio Vaccine Bulk (25 April 2019): Preparation, Cultivation, Inactivation, & Pooling. Certification validity period: April 24, 2024
13. Pertussis Vaccine Bulk (April 25, 2019): Preparation, Cultivation, Inactivation, & Pooling. Certification validity period: April 25, 2019
14. Antisera January 14, 2015: Antisera Formulation, Antisera Filling, Antisera Packaging. Certification validity period: January 14, 2025
15. Antisera January 14, 2015: Antisera Formulation, Antisera Filling, Antisera Packaging. Certification validity period: January 14, 2020
16. Bulk Batch Clinical Trials (Upstream) November 22, 2021: Substrate Preparation, Inoculation and Harvesting, Clarification and Purification, Bulk Filling. Certification validity period: November 22, 2021
17. Bulk Batch Clinical Trials (Downstream) (23 November 2021): Formulation, filling and freeze drying of clinical trial batch. Certification validity period: November 22, 2021
18. Bulk sIPV (May 18, 2017): Preparation and Cultivation of Vero cells, Polio Virus Inoculation, Harvesting, Purification, Inactivation, Neutralization, and Sterile Filtration. Certification validity period:
19. Bacterial Vaccine (September 17, 2018): Preparation, Cultivation, and Pooling of Bulk Pertussis. Certification validity
20. Polio Vaccine Bulk May 11, 2016: Kidney Preparation of Monkeys, Bulk Production. Certificate validity period:
21. Bacterial Vaccine (July 23, 2019): Preparation, Cultivation, purification, conjugation, Hib bulk sterile filtration. Certification validity period: July 22,
22. Bacterial Vaccine (July 23, 2019): Preparation, Cultivation, purification, conjugation, Thypoid bulk sterile filtration. Certification validity period: July 22, 2024

ISO 9001: 2015: From PT Lloyd’s Register Indonesia, for and on behalf of Lloyd’s Register Quality Assurance Limited.

ISO 14001: 2015: From PT Lloyd’s Register Indonesia, for and on behalf of Lloyd’s Register Quality Assurance Limited.

ISO 45001: 2018: From PT Lloyd’s Register Indonesia, for and on behalf of Lloyd’s Register Quality Assurance Limited, United Kingdom (LRQA - UK).

ISO 37001:2016 on Anti-Bribery Management Systems

PT BioFarma (Persero) is routinely inspected and audited by the ISO certification body, Lloyd’s Register Quality Assurance Limited (LRQA), through PT Lloyd’s Register Indonesia, on an annual basis in the form of Surveillance audits and periodic re-certifications every three years, and has consistently remained certified and in compliance with the required ISO requirements. PT BioFarma (Persero) has remained certified and in compliance with the required ISO requirements.

Laboratorium Mikrobiologi Bio Farma mendapatkan Akreditasi ISO 17025 untuk pengujian produk makanan, minuman dan kosmetik

ISO 14001:2004 certification for Environmental Management System wasgiven by Lloyd’s Register Quality Assurance Ltd., Singapore, valid until 30 juni 2016

Occupational, Health and Safety Management System–OHSAS 18001:2007 for the management of occupational security, safety and health was given by Lloyd’s Register Quality Assurance Ltd., Singapore. Valid until 16 September 2015.

Laboratory Accreditation Certificate was given by the world Health Organization (wHO) Regional South East Asia and Immunization and Vaccine Development (IVD) to Bio Farma for passing the accreditation for the laboratorium facility as a reference for polio laboratory test. Valid until December 2013.

Certificate of Honor from the world Health Organization (WHO) in implementing the use of Vaccine Vial Monitor (VVM) for Indonesia through Bio Farma.

Bio Farma received an appreciation from the Bill & Melinda Gates Foundation. This Certificate of Appreciation was given for Bio Farma’s commitment and dedication in improving global health, among others in eradicating polio disease by producing twothird of the world’s global demand for Oral Polio Vaccine (OPV).