MANAJEMEN

INDUSTRI FARMASI
Oleh : Drs. Irwan Setiono, Apt
Sejarah Perkembangan c-GMP
Daftar Istilah
ACTD = ASEAN Common Technical Dossier
ACTR = ASEAN Common Technical Raw Material
NRA = National Raw Material Agreement
ACCSQ = ASEAN Community Congress of
Standard Qualification
PIC = Pharmaceutical Inspection Convension
PIC/S = Pharmaceutical Inspection Cooperation
Scheme
APLAC = ASEAN Pharmaceutical Laboratory
Accreditation Committee
ILAC = International Laboratory Accreditation
Committee
GCP = Good Control Practice
GLP = Good Laboratory Practice

ASEAN Commitment
Commitment reaffirmation via Declaration of ASEAN
concord II in Oct 03 in Bali to create an ASEAN
Economic Community by 2020
ASEAN Leaders signed the Framework Agreement
for the integration of 11 priority sector on Nov 04
(The 10
th
ASEAN Summit, Vientine, Lao PDR 2004),
to fast track the economic integration process via
spesific protocols and roadmaps
11 priority sectors include Healthcare
ASEAN HELTHCARE SECTOR
INTEGRATION
AIMS :
Enhance the competitiveness of ASEAN
Strengthen regional integration efforts through
liberalization, facilitation and promotion
measure.
Promote private sector participation.
ROADMAP FOR INTEGRATION OF
PRIORITY SECTOR
MEASURE & TARGET DATE FOR THE ROADMAP
FOR HEALTHCARE INTEGRATION (pharma sector)
Target date
Study the feasibility of an ASEAN MRA for
pharma/medicinal product 30 Dec 2005

Implementation of the ACTD 31 Dec 2008

Harmonize labeling std for pharma/medicinal product 31 Dec 2006

Explore the feasibility of adopting a harmonized
placement system for pharma/medicinal product into
ASEAN market 31 Dec 2006

To facilitate the approval process (ASEAN X formula) After 31 Dec
The recognition after fully implementation of ACTD 2008

Explore the feasibility of implementing a flexible twining
system On-going

Formalize a Post Marketing alert system for defective &
unsafe pharma/medicinal product 31 Dec 2005
Target date for Implementation of ACTD
Singapore and Malaysia : 31 December 2005

Thailand : 31 December 2006

Vietnam and Indonesia : 31 December 2007

Brunei Darussalam, Cambodia
Lao PDR and Philippines : 31 December 2008
ASEAN Common Technical Dossier - ACTD
Quality :
- Drug Substance
- Drug Product
Process Validation
Analytical Method Validation
Stability
BA/BE study

Labeling

dll
11
th
ACCSQ - HANOI
Fase implementasi ACTD sudah mendekat
Taskforce BABE membuat draft kerangka kerja :
tujuan, timeline dll
Measure 44 : harmonisasi lebeling dianggap
selesai
Dialog Implementation Working Group (IWG)
dan ASEAN Pharmaceutical Industry Club
(APC)
Industry Readiness toward
ACTR-ACTD implementation
1. Raw materials
Agreed Compendial among ASEAN NRA
National Pharmacopoeia (for home country)
USP/BP/EP/JP/DAB
Alternative methods should be proven by
validation
Refference standards : Elaborate ASEAN
Reference Standard
Ref. Standard for impurities : from
manufacturers/institutin can be accepted
2. Process Validation
New registration : comply to ACTD :
Product with batch size of less than 100,000
units or production < 3 batches, special
consideration should be given
Product already in the market :
Critical change : compley to ACTD,
No change GMP requirement
Industry Readiness toward
ACTR-ACTD implementation
3. Analytical method validation
New registration : comply to ACTD
Renewal of product already in the market : no
need to submit, covered by GMP compliance
4. Stability study :
New registration and product with major
change : comply to ACTD
Product already exist in the market : no need
to submit data with new condition. Post
marketing stability study can be accepted
Consideration of permeable/impermeable
packaging needs to be discuss within expert
group
Industry Readiness toward
ACTR-ACTD implementation
5. BA BE study
Support MRA ASEAN BA BE report
Short and harmonized product list baseon scientific
data
Comparator ; innovator in any ASEAN country or if
not available refer to WHO list
Laboratory :
Certification by National Accreditation Body
which has signed in APLAC/ILAC MRA
Implement GCP & GLP
Independent in status
Industry Readiness toward
ACTR-ACTD implementation
6. MRA on GMP :
Agreed stepwise implementation
Mutual recognition of ASEANinspector
competence
Building confidence on audit findings among GMP
inspectorate
GMP Standard : Updated ASEAN GMP standard
(benchmark to PIC/S
Preparedness of ASEAN countries towards MRA
in GMP inspection
Validity period of GMP Audit
Industry Readiness toward
ACTR-ACTD implementation
Priority in ACTR-ACTD Implementation
New Registration
Existing product
ACTD compliance ACTD compliance
Lowest priority
Retrospective
Focus on public
service
Low prioruty
As of 1 January 2009
Home Country
Overseas
Mutual Recognation Agreement on GMP
inspection
Apa artinya ? Hasil / laporan audit dari 1 negara
diterima negara lain yang menandatangani
Kemana arahnya ? : Malaysia & singapore
anggota PIC/S
PIC/S 2004 Membership GMP Inspectorates of :
Australia Greece Norway
Austria Hungary Portugal
Belgium Iceland Romania
Canada Ireland Singapore
Czech Republic Italy Slovak Republic
Denmark Latvia Spain
Finland Liechtenstein Sweden
France Malaysia Switzerland
Germany Netherlands United Kingdom
PIC/S
Dimulai 1970 sebagai PIC
Pharmaceutical Inspection Convension
1993 : PIC/S : pharmaceutical Inspection
Cooperation Scheme
PIC versus PIC/S
PIC PIC/S
Convention Scheme
Between countries Between Agencies
A formal treaty Cooperative arrangement
Has legal status Has no legal status
Focus on inspection Focus on training
Mutual recognition Sharing of information
CHALLENGES FOR ASEAN MRA
ON GMP INSPECTION
Harmonization and
standardization of ASEAN
Requirement on GMP
The Code of
GMP Practice
WHO GL (1992, 2002)
ASEAN GL (1996
PIC/S 2004
PIC/S GMP std is
preferred by ASEAN
member countries
The Code of
GMP Practice
CHALLENGES FOR ASEAN MRA
ON GMP INSPECTION
Harmonization and
standardization of ASEAN
Requirement on GMP
The Quality System
of the inspectorate
Policies
Standard
SOPs
The Code of
GMP Practice
CHALLENGES FOR ASEAN MRA
ON GMP INSPECTION
Harmonization and
standardization of ASEAN
Requirement on GMP
The Quality System
of the inspectorate
PIC/S GMP
Reporet format
The GMP Inspection
Report
Conclusion : Challenges &
Opportunities
Current GMP and ASEAN Harmonized Requirements
and Products (ACTD, GL) for Registration
Opportunity for GLOBAL
and REGIONAL
Competitiveness
Challenges to accept
New Concept & to meet
New Requirements
Strengthening ASEAN pharmaceutical industry technical
& managerial competencies at regional / international level
Requires consistent COMMITMENT from :
Pharmaceutical industry in fulfilling requirement
Government in providing direction and regulatory support
Harmonisasi Regulasi Farmasi ASEAN
Merupakan bagian dari ASEAN Commitment
yang ditandatangani Pimpinan ASEAN ada 11
sektor prioritas termasuk kesehatan
Apa artinya ?
Pasar tunggal farmasi di ASEAN
Tidak ada barrier baik tarif maupun non tarif
Persaingan terbuka industri farmasi di ASEAN
Pemerintah tidak dapat memberi proteksi,
MRA GMP inspection
Mutu, keamanan dan khasiat
Indonesia pasar terbesar di ASEAN
Meningkatkan kapabilitas
Ketangguhan untuk bertahan tidak
menjadi tamu di negara sendiri
Daya saing untuk meningkatkan pasar
terutama di ASEAN
Sekali lagi mutu, keamanan dan khasiat
adalah kata kuncinya.
Harmonisasi Regulasi Farmasi ASEAN

Aspek CPOB yang Dinamis (c-GMP)

1. Umum
2. Sistem Manajemen Mutu
3. Bangunan, Sarana Penunjang dan Peralatan
4. Sistem Penanganan Bahan
5. Sistem Produksi
6. Sistem Pengemasan dan Penandaan
7. Sistem Pengawasan Mutu


c-GMP/ Current Good Manufacturing
Practice
PROFIL PENERAPAN C-GMP/CPOB Dinamis
189 IF
Jawa
93%
15 IF
Sumatera
7%
1 IF
Bali
0%
Jawa 189 IF
Sumatera 15 IF
Bali 1 IF
Sumber : Badan POM 2004
Peta Penyebaran Industri Farmasi
Berdasarkan Lokasi
ANALISA HASIL AUDIT BADAN POM, 2004
No. Persyaratan Pemenuhan (%) Rata-rata
C M m
1 Quality Assurance 65,05 44,78 45,75 51,86
2 Validasi 24,92 26,75 41,44 31,04
3 Stability 38,58 54,52 46,55
4 Produk Steril 54,52 69,15 54,30 59,32
5 Bangunan 46,12 44,16 47,51 45,93
6 Water System 53,01 53,66 35,65 47,44
7 HVAC 26,01 28,23 27,12
8 Dokumentasi 71,42 43,65 53,39 56,15
Rata-rata 48,72 43,62 47,51 46,62
C = Critical M = Major m = Minor
TANTANGAN INDUSTRI FARMASI
INDONESIA
Peningkatan compliance terhadap persyaratan &
standart pharma global
Penerapan CPOB yang dinamis (c-GMP) sesuai
standart internasional (dateline : Des 2006)
Industri farmasi Nasional agar lebih efisien dan fokus
dalam pelaksanaan produksi obat termasuk pemilihan
fasilitas produksi yang paling feasible untuk
dikembangkan
Peran Pharmacist ??
Kompetensi Pharmacist ??
Kurikulum Pendidikan Tinggi Farmasi ??
PROFIL INDUSTRI FARMASI DI INDONESIA
Hormon
Steril
AB
Sefalosporin
AB Penisilin
Antibiotik Non
Betalaktam
Non Antibiotik
193
137
64
55
19
9
Sumber : Badan POM 2004
Peta Penyebaran Industri Farmasi Berdasarkan Sertifikat CPOB
KOMPETENSI APOTEKER DI INDUSTRI
FARMASI
1. Care Giver
Memberi pelayanan di industri farmasi dalam bentuk
informasi obat, efek samping obat (ESO), informasi
analitis mengenai hal-hal yang berhubungan dengan
obat dll
2 Decision Maker
Pengambil keputusan yang tepat untuk
mengefisienkan dan mengefektifkan sumber daya
yang ada di industri seperti pengendalian bahan awal
dan obat jadi, alokasi dana yang sesuai dengan
kebutuhan, operasi mesin-mesin produksi,
pemanfaatan SDM dan strategi yang tepat dalam
memasarkan dan mengenalkan obat kepada
masyarakat