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-