PROMOTING GMP- COMPLIANT BLOOD MANAGEMENT PRACTICES IN INDONESIA

Transcription

1 PROMOTING GMP- COMPLIANT BLOOD MANAGEMENT PRACTICES IN INDONESIA Bayu Wibisono, S.Si., Apt. BADAN POM RI 3 rd APEC Blood Supply Chain Policy Forum Hanoi, 8 9 December 2016

2 Outline INTRODUCTION CURRENT SITUATION OF BLOOD SERVICE IN INDONESIA ROLE OF BPOM ON PROMOTING GMP COMPLIANCE THE CHALLENGES SUMMARY 2

3 INTRODUCTION

4 COUNTRY PROFILES Biggest archipelago country in Asia Total population :± Area : ± km2 with ± islands INDONESIA 34 provinces & 502 cities/regencies 4

5 BADAN POM REPUBLIC OF INDONESIA VISION Safe Food and Medicine to Improve Public Health and National Competitiveness. MISSION Intensifying Risk-based Drug and Food Control System to protect public health Encouraging Self Reliance of Business Actors in ensuring Drug and Food Safety and strengthening partnership with stakeholders Enhancing BPOM institutional capacity. 5

6 STRATEGIC ROLE OF BADAN POM Enhancing quality, safety, and efficacy assurance of Drug and Food in order to increase public health Enhancing competitiveness of Drug and Food in local and global market, with assuring the quality and supporting the innovation 6

7 ORGANIZATION STRUCTURE OF BADAN POM MINISTRY OF HEALTH Coordination NATIONAL AGENCY OF DRUG AND FOOD CONTROL INSPECTORATE PERMANENT SECRETARY 1. Bureau of Planning and Financing 2. Bureau of International Cooperation 3. Bureau of Legal and Public Relation 4. Bureau of General Affairs National Laboratory of Drug and Food Control Centre of Drug And Food Investigation Centre of Drug And Food Research Centre of Drug And Food Information Deputy I Therapeutic Products, Narcotics, Psychotropic and Addictive Control Deputy II Traditional Medicines, Cosmetics and Complementary Products Control Deputy III Food Safety and Hazardous Substance Control 31 Regional Office (RO): 19 Main Regional Office and 12 Regional Office Each RO has its own GMP Inspector and Laboratory SECRETARIAT FUNCTIONAL GROUP Laboratory Division For Therapeutic Product, Narcotic, Traditional Medicines and Cosmetic Laboratory Division For Food and Hazardous Substances Laboratory Division for Microbiology Inspection and investigation Division Certification and Information Division

8 Deputy I Therapeutic Products, Narcotics, Psychotropic and Addictive Substance Control Directorate of Drug and Biological Product Evaluation Directorate of Control Medical of Devices,Diagno Distribution of Therapeutic stic and & Households Healthcare Product Prod. evaluation Directorate Directorate of Standardization Standardization of Therapeutic of & Therapeutic Households Product Product Directorate of Directorate Control of Inspection and Production of Certification of Therapeutic & Therapeutic Households Product Product Directorate of Narcotics, Psychotropic & Directorate of Narcotics, Addictive Substance Psychotropic Control & Addictive Substance Control Sub Directorate of New Drug Evaluation Sub Directorate of Copy Drug and Biological Product Evaluation Sub Directorate Therapeutical Product & Special Access Scheme Evaluation Sub Directorate of Distribution of Therapeutic and Households Product Inspection & Certification Sub Directorate of Promotion and Labeling of Therapeutic & Household Product Control Sub Directorate of Surveillance & Risk Analysis of Therapeutic & Household Product Sub Directorate of Standardization and Regulation of Therapeutic and Household Product Sub Directorate of Standardization and Evaluation of BA/BE Sub Directorate of Technical Guidance for Pharmaceutical Industry Sub Directorate of Therapeutic and Households Product Inspection & Certification Sub Directorate of Pharmacoecono mic and Drug Pricing Control Sub Directorate Control of Drug Substance and GMP Analysis Sub Directorate of Narcotics Control Sub Directorate of Psychotropic Control Sub Directorate of Precursor Control Sub Directorate of Tobacco control

9 NATIONAL NETWORKING OF DRUG AND FOOD CONTROL SYSTEM DI ACEH MEDAN SULUT KAL-BAR RIAU SUMBAR MALUKU UTARA KAL-TIM SULTENG JAMBI KAL-TENG PALEMBANG KAL-SEL BENGKULU LAMPUNG BANTEN BADAN POM NADFC MALUKU IRJA SULTRA JAKARTA BOBEK SEMARANG SURABAYA BANDUNG NTB YOGYA DENPASAR 33 Regional Offices MAKASSAR NTT

10 CURRENT SITUATION OF BLOOD SERVICE IN INDONESIA

11 Current Situation of Blood Establishment Indonesia has 379 Blood Transfusion Units (BTUs) : 207 IRC BTUs 172 Government BTU (MoH, 2014) Total donation : 4,6 million bags of blood and blood components (MoH, 2015) Population : ± 250 million people Potential plasma source Problems : The BTUs are distributed in 34 provinces Varies condition and quality between BTUs Blood products or plasma which do not meet the quality requirements risk of disease transmission High waste of poor quality plasma (± L/year) high cost, plasma potential is not utilized All plasma derivative products in Indonesia are imported expensive 11

12 Strategy to Increase Blood Safety and Quality Indonesia South Africa WHA (WHO, 2010) Availability, Safety, & Quality of Blood Products OBJECTIVES Increase the availability, safety, quality and accesibility of blood products Encourage the developing country to use its own plasma as raw material for plasma fractionation STRATEGY Blood Establishment GMP Implementation Presidential Instruction #6/2016 Plasma apheresis Centre Plasma source for fractionation Badan POM has a role in the supervision of GMP Compliance Establishing Local Plasma Fractionator

13 BPOM s Legal Basis on Blood Products Supervision Blood services are run by Blood Transfusion Unit (BTU) either under government or IRC Health Law No.36/2009 Government is responsible for safe blood supply Government Regulation No. 7/2011 Blood Service BPOM is responsible for quality of blood MOH Decree 83/2014 Blood Transfusion Unit, Hospital Blood Bank Blood Establishment and fractionation facility should comply with the GMP standards. GMP inspection is conducted by BPOM MOH Decree 72/2015 Plasma Fractionation BPOM can take administrative action for National Standard violation Some aspect of the National Standard are refer to GMP Guideline for Blood Establishment MOH Decree 91/2015 National Standard on Blood Services

14 THE ROLE OF BPOM ON PROMOTING GMP COMPLIANCE

15 Training/workshop that involving the BTU s personnels and GMP inspectors Aim to increase the understanding of GMP for Blood Establishment to the BTU s personnels and GMP inspectors Same perception on GMP requirements/ implementation Regulation Certification scheme Indonesian Blood Guideline: GMP for Blood Establishment (ref: WHO Annex 4, TRS 961 (2011) & PIC/S PE (2007) Technical Guidance/ Operational Manual of GMP for Blood Establishment specific guideline explanation Capacity Building GMP Regulatory Assistance Aims to identify the GMP implementation gap in BTUs, and giving assistance to comply with GMP standards.

16 Updating Regulation 5 IRC BTUs : Central BTU, Bandung, DKI Jakarta, Solo, Surabaya Revision the existing Indonesian GMP for Blood Establishment. Public consultation of the guideline GMP Regulatory Assistance 6 IRC BTUs: DKI Jakarta, Bandung, Solo, Surabaya, Semarang, Bali Guideline Finalization; Certification scheme to include Blood Transfusion Unit; Socialization the guideline to BTU in west region and central region 7 IRC BTUs: Cirebon, Bekasi, Makassar, Lampung, Pekanbaru, Bandung and Central BTU 2017 (Plan) Socialization the guideline to BTU in east region Publishing the GMP Guideline and Operational Manual 10 IRC BTUs: DKI Jakarta, Padang, Pekanbaru, Banjarmasin, Semarang, Bali, Solo, Banyumas, Sidoarjo, Malang GMP certification Seminar on Blood and Regulation Control (WHO) Blood Testing and Risk Assessment as Part of GMP in Blood Establishment (WHO) Enforcement and Implementation of Good Manufacturing Practices for Blood Establishments (WHO) Capacity Building General GMP Training GMP training Training on GMP for BE Training on GMP for BE Assesment of GMP Implementation on Surabaya IRC BTU (by WHO) 16

17 CHALLENGES

18 Blood Establishment VS GMP Inspector VS Indonesia has 379 BTUs that are distributed in 502 cities/regencies. BPOM has 33 regional offices in 34 provinces Total GMP inspectors are 114 persons. The GMP inspectors only available in central office and 9 regional office Not all of the inspector familiar with blood services. Possibilities that the BTUs were not reached by inspection system/catchment areas of BPOM inspectors Inspectors from 24 Regional Offices have not been trained on GMP aspects : Basic knowledge on GMP aspect is not sufficient need special inspectors trained in GMP, QMS, and familiar with blood service. 18

19 GMP IMPLEMENTATION CHALLENGES CHALLENGES GMP mindset in blood establishment services Quality must be built and integrated to the product from entire manufacturing process (collection, preparation, storage, testing and distribution of blood products) How to create a similar perception of GMP in all BEs GMP environment (QMS, IT requirements, traceability, qualification & validation, technical capacity both in BEs and BPOM) ACTION NEED Cooperation and strong commitment between stakeholder to assure availability, safety and quality of blood products. Sharing knowledge/workshop on GMP Implementation GMP Training/capacity building for both BEs personnel and GMP inspectors could APEC support??? 19

20 Activities Conducted on (1) WHO Seminar on Blood Regulation and Control Jakarta, Agustus 2013 WHO Workshop on Blood Testing and Risk Assessment as part of GMP in Blood Establishment Jakarta, 9-12 June

21 Activities Conducted on (2) WHO Assessment of GMP Implementation on Surabaya BTU (11 14 Agustus 2015) 21 Basic GMP Training (involving BPOM & BTU personnel) Training on GMP for Blood Establishment (Desember 2015)

22 Activities Conducted on (3) Public Consultation on Draft GMP for Blood Establishment (Jakarta, 21 December 2015) 22

23 Activity (4) Advanced GMP Training (May 2016) Socialization of GMP for Blood Establishment (Bandung, August 2016) Socialization of GMP for Blood Establishment(Surabaya, Agustus 2016) 23

24 SUMMARY Enforcing the compliance with GMP in blood establishments by the competent national regulatory authority has become an important tool to confirms the assurance of quality and safety of blood products. Role of BPOM on Promoting GMP Compliance : Updating Regulation as guideline for implementing GMP in BEs Capacity Building of GMP Inspector & BE s Personnels GMP regulatory assistance in Blood Establishment GMP certification Scheme for BE. Challenges : insufficient GMP inspector that were trained in blood establishment activities, encourage the GMP Mindset and create similiar perception of GMP in BEs, adequate GMP environment Need close cooperation between RA, MoH and IRC in improving the quality of blood products 24

25