HALAL VACCINE, INDONESIA EXPERIENCE 1 st International Halal - - PowerPoint PPT Presentation

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 Bandung in 1923

Implement Integrated System GMP, 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

2003

TT Uniject 1 ds

2004

• Hep. B Uniject

DTP-HB 5 ds DTP-HB 10 ds

2006

Measles 20 ds

2009

mOPV Type 1 - 20ds

2010

bOPV 20 ds

2011

Td 10 ds

2014

Pentabio 5 ds Pentabio 10 ds

2015

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 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 purification Formulation Filling packaging QC Test Final Product

DISTRIBUTION VALIDATED COLD CHAIN TEMPERATURE MONITORING

SELF RELIANCE IN PRODUCTION AND SUPPLY OF VACCINES

Bio Farma

The Republic

• f 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 Implementation

• f the OIC Strategic Health Program of Action

OIC VACCINE MANUFACTURER GROUP Self 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 Arabia Deputy 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 - 3 Training & 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 - 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 & 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-