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HALAL VACCINE,
INDONESIA EXPERIENCE
DR. RAHMAN ROESTAN
Director Bio Farma, OIC-VMG Vice Chairman
1st International Halal Dialogue 2019
Jakarta, 12 November 2019
OUTLINE
BIO FARMA IN BRIEF
HALAL VACCINE
SELF RELIANCE IN PRODUCTION AND SUPPLY OF VACCINES
CHALLENGES
Established
in Aug 6, 1890
Moved to Bandungin 1923
Implement Integrated SystemGMP, GLP, GCP, ISO9001, ISO14001,
OHSAS18001, ISO 17025, ISO 27001
ERM, CSR Based ISO 26000
State-owned Enterprise (100 %)Vaccine & Antiserum manufacturer
1300 Employee
Knowledge-based, R&D-based Driven
Export to more than 140 countries (52 OIC countries)
1997
tOPV 10 ds
tOPV 20 ds
Measles 10 ds
1999
TT 10 ds
TT 20 ds
DT 10 ds 2001
DTP 10 ds
2003TT Uniject 1 ds
2004
Hep. B Uniject
DTP-HB 5 ds
DTP-HB 10 ds
2006Measles 20 ds 2009
mOPV Type 1 - 20ds
2010bOPV 20 ds
2011
Td 10 ds
2014Pentabio 5 ds
Pentabio 10 ds2015
bOPV 10 ds
2019
mOPV Type 2
List of Products WHO PQ Milestone
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)
Hasanuddin
University
National Collaboration
Consortiums on Vaccine Research
➢ Rotavirus
➢ New TB
➢Malaria
➢ HIV
Consortium Members
➢ Dengue
➢ H5N1 (Influenza, AI)
➢ Pneumococcus
➢ Hepatitis B
➢ HPV
Ministry of
Health
Indonesia
University
Bandung Institute of
Technology
Padjadjaran
University
Gadjah Mada
University
Airlangga
University
Brawijaya
University
PT. Bio Farma Eijkman Institute
Bogor Institute of
Agriculture
Al Azhar Indonesia University Agency for the Assessment
and Application of Technology
Indonesian
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.
PERSONNEL UTILITIES - FACILITIES MANUFACTURING/PRODUCTION
PACKAGING AND LABELING QUALITY CONTROL COMPLAINS AND PRODUCT RECALL
DOCUMENTATION SELF INSPECTION VALIDATION
cGMP : Quality, Safety + Efficacy (Thoyyib)Free from Chemical, Physical, Biological Hazard
Pharmaceutical, Biological Derived product
www.themegallery.com Company Logo
Materials Source in pharmaceutical manufacture
Source of Active and pharmaceutical ingredients
Plants
Animals Bacteria
Synthetic Chemicals
Human
Virus
Doc. Requirements of Raw Material
Raw
Material
Halal
Cert.CoA
Flow
Process
Other
Docs: Spec,
MSDS
Supporting data requested :
1. COA
2. Flow of process
3. Statement of porcine free
Dedicated Facility ?
Cleaning Validation
(Najis Cleaner) ?
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 shariahrequirements 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
purification Formulation Filling
packaging
QC TestFinal
Product
DISTRIBUTION
VALIDATED COLD CHAIN
TEMPERATURE MONITORING
SELF RELIANCE IN PRODUCTION AND
SUPPLY OF VACCINES
Bio Farma
The Republic
of Indonesia
WHO
(World Health Organization)
DCVMN(Developing
Countries Vaccine Manufacturers
Network)
OIC (Organization of
Islamic Cooperation)
To secure National Vaccine
availability : Vaccine Self-
Reliance
To Secure Global
Vaccine Supply :
Pre-Qualified WHO/
UNICEF
(GLOBAL PLAYER)Vaccine Self-Reliance in
developing countries
Vaccine self-reliance
In OIC member countries
STRATEGIC ROLES OF BIO FARMA
Report on Implementationof the OIC Strategic Health Program of Action
OIC VACCINE MANUFACTURER GROUPSelf Reliance in Production and Supply of Vaccines
OIC VMG ACTIVITIES
JEDDAH, 25 – 26 JUNI 2014 : OIC VMG Meeting -1(launched 25-26 June 2014)Chair : Arabio, Saudi ArabiaDeputy Chair : Bio Farma, Indonesia
Pasteur Institute de Tunis, Tunisia
TUNISIA, 12 – 13 MAY 2015 : OIC VMG Meeting – 2 : Sharpening Plan of Action
BANDUNG, 14 – 15 NOV 2016 : OIC VMG Meeting - 3Training & Workshop Program
FACILITATORS : WHO SEARO, MOH of
INDONESIA, NRA, BIO FARMA
WORKSHOP ON VACCINE MANAGEMENT
The 6th Islamic Conference Ministry Of Health, 5-7 desember 2017
INDONESIA : As a Center of Excellence Vaccine and Biotech Product
STRENGTHENING INDONESIA – MAROCO - TUNISIADEVELOPMENT 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 & HARMONIZATION
Research Forum
A
B
C
G
PT ACQUIRED TECHNOLOGY
RESEARCH TRANSFER• WORKING GROUP
• RESEARCH CONSORTIUM
RESEARCH HARMONIZATION
UNIV
INDUSTRY
ULAMA
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-