HALAL VACCINE, INDONESIA EXPERIENCE 1 st International Halal Dialogue 2019 Jakarta, 12 November 2019 DR. RAHMAN ROESTAN Director Bio Farma, OIC-VMG Vice Chairman
OUTLINE BIO FARMA IN BRIEF HALAL VACCINE SELF RELIANCE IN PRODUCTION AND SUPPLY OF VACCINES CHALLENGES
State-owned Enterprise (100 %) Vaccine & Antiserum manufacturer Established Moved to Bandung Knowledge-based, R&D-based Driven in 1923 in Aug 6, 1890 Implement Integrated System GMP, GLP, GCP, ISO9001, ISO14001, Export to more than 140 OHSAS18001, countries (52 OIC countries) ISO 17025, ISO 27001 1300 Employee ERM, CSR Based ISO 26000
List of Products WHO PQ Milestone 2014 Pentabio 5 ds Pentabio 10 ds 2015 2010 2019 2011 bOPV 20 ds 2006 1999 Measles 20 ds 2009 Td 10 ds 2003 bOPV 10 ds TT 10 ds TT Uniject 1 ds 2004 mOPV Type 2 TT 20 ds mOPV Type 1 - 20ds 2001 DT 10 ds Hep. B Uniject DTP-HB 5 ds DTP 10 ds 1997 DTP-HB 10 ds tOPV 10 ds tOPV 20 ds Measles 10 ds 4
Biotech Product Manufacturers in Asia and Emerging Countries
Ref : WHO, 2013
VACCINES COMPONENTS Antigens Adjuvant (immunogenicity enhancer) Stabilizer • To avoid chemical reaction • Sugar as cryoprotectant for freezed dried vaccine. Other exipients (especially for novel vaccine delivery)
National Collaboration Consortiums on Vaccine Research ➢ Dengue ➢ Rotavirus ➢ H5N1 (Influenza, AI) ➢ New TB ➢ Pneumococcus ➢ Malaria ➢ Hepatitis B ➢ HIV ➢ HPV Consortium Members Brawijaya Bogor Institute of Airlangga Hasanuddin Ministry of Indonesia Bandung Institute of Padjadjaran Gadjah Mada University Agriculture University Health University Technology University University University Eijkman Institute Al Azhar Indonesia University PT. Bio Farma Agency for the Assessment Indonesian and Application of Technology Science Institute 9
Halal Pharmaceutical • Pharmaceutical products that contain ingredients permitted under the Shariah law & fulfill the following conditions: – do not contain any parts or products of animals that are non - halal or any parts or products of animals which are not slaughtered according to Shariah law; – do not contain najs – Safe for consumption, non-poisonous, non-intoxication, non- hazardous to health according prescribed doses.
Halal Pharmaceutical – Not prepared, processed or manufactured using equipment contaminated with najs. – Do not contained human parts or its derivatives that are not permitted by shariah law. – During its prepared, processed, manufactured, packing, storage and distribution should be separated from other pharmaceuticals that do not meet halal requirements by shariah law.
cGMP : Quality, Safety + Efficacy (Thoyyib) Free from Chemical, Physical, Biological Hazard Pharmaceutical, Biological Derived product PERSONNEL UTILITIES - FACILITIES MANUFACTURING/PRODUCTION PACKAGING AND LABELING QUALITY CONTROL COMPLAINS AND PRODUCT RECALL DOCUMENTATION SELF INSPECTION VALIDATION
www.themegallery.com Company Logo
Materials Source in pharmaceutical manufacture Animals Human Bacteria Source of Active and pharmaceutical ingredients Synthetic Plants Virus Chemicals
Doc. Requirements of Raw Material Halal CoA Raw Cert. Material Other Flow Docs: Spec, Process MSDS Dedicated Facility ? Supporting data requested : Cleaning Validation 1. COA (Najis Cleaner) ? 2. Flow of process 3. Statement of porcine free
Facility & Equipment System • Layout and design of the premise must be in accordance with GMP or PIC/s layout design requirement. • Premise must be well separated by distance and other means from any non-halal animal activity area to prevent cross contamination through air, water, personnel or sewage. • Design and construction of equipment used for halal products must be in accordance with shariah requirements as well as GMP requirements.
Facility & Equipment System • Premise and equipment must be dedicated for the manufacturing of halal pharmaceuticals. • Equipment MUST NOT be in contact with or contaminated with najs . Otherwise, equipment must go through cleansing process
Production System • Logistics: Halal pharmaceuticals are physically segregated during handling and storage from non-halal products. • The production and storage area of pharmaceutical product shall be provided with dedicated and self-sufficient facility so that it can minimise the chance of contamination of product or ingredients to become non-halal. • If the halal pharmaceutical is in need of animal facility, then the animal handling area must be isolated from other manufacturing areas; with different entrance for animal access and different air handling unit.
Laboratory Control System • The quality control system must comply with halal requirements as well as with GMP requirements. • The procurement of chemical, reagents or other ancillary equipment required for sampling and testing must not be made using materials that are not halal or dubious. • Precautions must be taken to prevent contamination that may affect the halal nature of product during conducting quality control activities in production area. • Able to investigate presence of porcine
Production Antigen Formulation purification Filling packaging Final QC Test Product
DISTRIBUTION VALIDATED COLD CHAIN TEMPERATURE MONITORING
SELF RELIANCE IN PRODUCTION AND SUPPLY OF VACCINES
STRATEGIC ROLES OF BIO FARMA The Republic To secure National Vaccine availability : Vaccine Self- of Indonesia Vaccine self-reliance Reliance In OIC member countries OIC WHO Bio (World Health (Organization of Farma Islamic Organization) Cooperation) To Secure Global Vaccine Supply : DCVMN Pre-Qualified WHO/ UNICEF (Developing (GLOBAL PLAYER) Countries Vaccine Vaccine Self-Reliance in Manufacturers Network) developing countries
Report on Implementation of the OIC Strategic Health Program of Action OIC VACCINE MANUFACTURER GROUP Self Reliance in Production and Supply of Vaccines
OIC VMG ACTIVITIES BANDUNG, 14 – 15 NOV 2016 : OIC VMG Meeting - 3 Training & Workshop Program TUNISIA , 12 – 13 MAY 2015 : WORKSHOP ON VACCINE OIC VMG Meeting – 2 : MANAGEMENT Sharpening Plan of Action JEDDAH, 25 – 26 JUNI 2014 : OIC VMG Meeting -1 (launched 25-26 June 2014) Chair : Arabio, Saudi Arabia Deputy Chair : Bio Farma, Indonesia Pasteur Institute de Tunis, Tunisia FACILITATORS : WHO SEARO, MOH of INDONESIA, NRA, BIO FARMA
The 6th Islamic Conference Ministry Of Health, 5-7 desember 2017 INDONESIA : As a Center of Excellence Vaccine and Biotech Product
STRENGTHENING INDONESIA – MAROCO - TUNISIA DEVELOPMENT COOPERATION THROUGH REVERSE LINKAGE PROGRAM : KNOWLEDGE SHARING ON VACCINE MANAGEMENT, AUGUST 2018
Workshop on Cold Chain Management, 1-2 Oct 2019 Afghanistan – Bangladesh - Brunei Darussalam – Gambia – Indonesia – Malaysia – Maldives – Morocco – Nigeria – Somalia – Sudan – Tunisia – Turkey – Uganda OIC – WHO – Indonesian MoH – Indonesian NADFC - Bio Farma
CHALLENGES
RESEARCH COLLABORATION A & HARMONIZATION G B Research Forum RESEARCH TRANSFER • WORKING GROUP • C RESEARCH CONSORTIUM ACQUIRED PT UNIV TECHNOLOGY ULAMA INDUSTRY RESEARCH HARMONIZATION
GLOBAL POLIO ERADICATION PROGRAM
International Halal Accreditation Forum IHAF, DUBAI
RECOMMENDATION • Complexity of research and development of biotechnology production technology: Pentahelix forum starts from R & D stage : academia, industry, government, media and community accompanied by Ulema. • The majority of Pharmaceutical Raw Materials are still imported: Cross-sectoral coordination: academia, research institutions and relevant ministries contribute to Halal criteria of medical products and vaccines. • Global Forum to identify technological progress resolution to determine Halal Criteria in OIC / OIC member countries
-THANK YOU-
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