WORLD HEALTH ORGANIZATION (WHO)

Recognition from the world Health Organization (wHO) for polio vaccines (9 April 1997), measles 10 doses & 20 doses (9 April 1997 & 4 September 2006), Hepatitis B Uniject (13 May 2004), Oral Polio Vaccine Tipe 1/mOPV-1 monovalent (3 November 2009), Oral Polio Vaccine/bOPV bivalent (26 May 2010), bacterial vaccines (Diphtheria, Pertussis, Tetanus) (6 April 2011), Tetanus in vial form (11 March 1999) & Uniject (29 October 2003), Td (6 July 2011), DT (11 March 1999) and DTP-HB combination vaccine, have all passed the wHO prequalified test (7 October 2004), Pentabio (16 December 2014).

AKREDITASI ISO 9001 : 2015

27-Jun-16

Bio Farma mendapatkan sertifikat ISO 9001 : 2015 mengenai Standar Manajemen Mutu yang diberikan oleh L'loyds Register Quality Assurance tanggal 27 Juni 2016 - 26 Juni 2019

AKREDITASI ISO 17025

17-Feb-16

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

CPOB CERTIFICATE

CPOB (Good Manufacturing Practice) from National Agency of Drugs and Food Control of the Republic of Indonesia :

  1. Polio Vaccine: Manufacturing Of Bulk Antigens Type1,2 And  3, Validity Until 4 Apr 2016.
  2. Measles Vaccine:Formulation,Filling, Liophilization Of Measles Vaccine, Validity Until 4 Apr 2016.
  3. Bacterial Vaccines : Preparation Of Bulk Pertussis Production, Cultivation For Bulk Pertussis Production, Pooling For Bulk Pertussis Production, Preparation For Bulk Hib Production, Cultivation For Bulk Hib Production, Conjugation & Purification For Bulk Hib Production, Validity Until 16 Sep 2018.
  4. Bulk Measles Vaccine: Breeding Of SPF Chicken, Bulk Production, Validity Until 31 Mar 2019.
  5. Bulk BCG: Bulk Production, Validity Until 31 Mar 2019
  6. Diphtheria Toxoid Bulk: Bulk Production (Cultivation & Detoxification), Bulk Production (Purification), Lidity Until 31 Mar 2019.
  7. Tetanus Toxoid Bulk: Bulk Production (Cultivation & Detoxification),Bulk Production (Purification), Alidity Until 31 Mar 2019.
  8. Viral Vaccine : Formulation, Filling, Liofilisasi Measles  Vaccine, Measles Vaccine Ackaging, Formulation, Polio Vaccine Filling, Polio Vaccine Packaging, Formulation, Hepatitis B Vaccine Filling, Hepatitis B Vaccine Packaging, Formulation, Influenza Seasonal Vaccine Filling, Influenza Seasonal Vaccine Packaging, Validity Until 31 Mar 2019.
  9. Bacterial Vaccine: Formulation, Filling, Liofilisasi BCG Vaccine, BCG  Vaccine Packaging , Validity Until 31 Mar 2019.
  10. Bacterial Vaccines: Formulation, Filling Of DTP Vaccine, DTP Vaccine Packaging, Formulation, Filling Of TT Vaccine, TT Vaccine Packaging, Formulation, Filling Of DT Vaccine, DT Vaccine Packaging, Ormulation, Filling Of Td Vaccine, Td Vaccine Packaging, Validity Until 31 Mar 2019.
  11. Combination Vaccines : Formulation, Filling Of DTP-HB Vaccine, DTP-HB Vaccine Packaging,Formulation, Filling Of DTP-HB-Hib Vaccine, DTP-HB-Hib Vaccine Packaging, Validity Until 31 Mar 2019.
  12. Bulk Pertussis Vaccine: Reparation, Cultivation, Inactivation And Pooling, Validity Until 31 Mar 2019.
  13. Bulk Polio Vaccine : Bulk Production, Validity Until31 Mar 2019.
  14. Bulk Antisera: Separation & Pooling Of Plasma, Bulk Production, Validity Until 14 Jan 2020.
  15. Antisera:Formulation Of Antisera, Filling Of Antisera, Packaging Of Antisera, Validity Until 14 Jan 2020.
QUALITY MANAGEMENT SYSTEM –ISO 9001:2008 SNI ISO 9001:2008

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

ENVIROMENTAL MANAGEMENT SYSTEM ISO 14001:2004
OCCUPATIONAL, HEALTH AND SAFETY MANAGEMENT SYSTEM-OHSAS 18001:2007

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.

SERTIFIKAT LABORATORY ACCREDITATION DARI WHO REGIONAL SOUTH EAST ASIA

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.

SERTIFIKAT VACCINE VIAL MONITOR (VVM)

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

BILL & MELINDA GATES FOUNDATION CERTIFICATE OF APPRECIATION

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).