MANAJEMENINDUSTRI FARMASIOleh : Drs. Irwan Setiono, Apt

Sejarah Perkembangan c-GMP

Daftar IstilahACTD= ASEAN Common Technical DossierACTR = ASEAN Common Technical Raw MaterialNRA = National Raw Material AgreementACCSQ= ASEAN Community Congress of Standard QualificationPIC= Pharmaceutical Inspection ConvensionPIC/S= Pharmaceutical Inspection Cooperation SchemeAPLAC= ASEAN Pharmaceutical Laboratory Accreditation CommitteeILAC= International Laboratory Accreditation CommitteeGCP= Good Control PracticeGLP= Good Laboratory Practice

ASEAN CommitmentCommitment reaffirmation via Declaration of ASEAN concord II in Oct 03 in Bali to create an ASEAN Economic Community by 2020ASEAN Leaders signed the Framework Agreement for the integration of 11 priority sector on Nov 04 (The 10th ASEAN Summit, Vientine, Lao PDR 2004), to fast track the economic integration process via spesific protocols and roadmaps11 priority sectors include Healthcare

ASEAN HELTHCARE SECTOR INTEGRATIONAIMS :Enhance the competitiveness of ASEANStrengthen regional integration efforts through liberalization, facilitation and promotion measure.Promote private sector participation.ROADMAP FOR INTEGRATION OFPRIORITY SECTOR

MEASURE & TARGET DATE FOR THE ROADMAP FOR HEALTHCARE INTEGRATION (pharma sector) Target dateStudy 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 product31 Dec 2006

Explore the feasibility of adopting a harmonized placement system for pharma/medicinal product into ASEAN market31 Dec 2006

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

Explore the feasibility of implementing a flexible twining systemOn-goingFormalize a Post Marketing alert system for defective & unsafe pharma/medicinal product31 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, CambodiaLao PDR and Philippines: 31 December 2008

ASEAN Common Technical Dossier - ACTD Quality :- Drug Substance- Drug ProductProcess ValidationAnalytical Method ValidationStabilityBA/BE study

Labeling

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11th ACCSQ - HANOIFase implementasi ACTD sudah mendekatTaskforce BABE membuat draft kerangka kerja : tujuan, timeline dllMeasure 44 : harmonisasi lebeling dianggap selesaiDialog Implementation Working Group (IWG) dan ASEAN Pharmaceutical Industry Club (APC)

Industry Readiness towardACTR-ACTD implementationRaw materialsAgreed Compendial among ASEAN NRANational Pharmacopoeia (for home country) USP/BP/EP/JP/DABAlternative methods should be proven by validationRefference standards : Elaborate ASEAN Reference StandardRef. Standard for impurities : from manufacturers/institutin can be accepted

Industry Readiness towardACTR-ACTD implementation2. Process ValidationNew 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 towardACTR-ACTD implementation3. Analytical method validationNew registration : comply to ACTDRenewal of product already in the market : no need to submit, covered by GMP compliance4. Stability study :New registration and product with major change : comply to ACTDProduct already exist in the market : no need to submit data with new condition. Post marketing stability study can be acceptedConsideration of permeable/impermeable packaging needs to be discuss within expert group

Industry Readiness towardACTR-ACTD implementation5. BA BE studySupport MRA ASEAN BA BE reportShort and harmonized product list baseon scientific dataComparator ; innovator in any ASEAN country or if not available refer to WHO listLaboratory :Certification by National Accreditation Body which has signed in APLAC/ILAC MRAImplement GCP & GLPIndependent in status

Industry Readiness towardACTR-ACTD implementation6. MRA on GMP :Agreed stepwise implementationMutual recognition of ASEANinspector competenceBuilding confidence on audit findings among GMP inspectorateGMP Standard : Updated ASEAN GMP standard (benchmark to PIC/SPreparedness of ASEAN countries towards MRA in GMP inspectionValidity period of GMP Audit

Priority in ACTR-ACTD ImplementationNew RegistrationExisting productAs of 1 January 2009Home CountryOverseas

Mutual Recognation Agreement on GMP inspectionApa artinya ? Hasil / laporan audit dari 1 negara diterima negara lain yang menandatanganiKemana arahnya ? : Malaysia & singapore anggota PIC/S

PIC/S 2004 Membership GMP Inspectorates of :AustraliaGreeceNorwayAustriaHungaryPortugalBelgiumIcelandRomaniaCanadaIrelandSingaporeCzech RepublicItalySlovak RepublicDenmarkLatviaSpainFinlandLiechtensteinSwedenFranceMalaysiaSwitzerlandGermanyNetherlandsUnited Kingdom

PIC/SDimulai 1970 sebagai PIC Pharmaceutical Inspection Convension1993 : PIC/S : pharmaceutical Inspection Cooperation Scheme

PIC versus PIC/S

CHALLENGES FOR ASEAN MRA ON GMP INSPECTIONThe Code of GMP Practice WHO GL (1992, 2002) ASEAN GL (1996 PIC/S 2004PIC/S GMP std is preferred by ASEAN member countries

The Code of GMP PracticeCHALLENGES FOR ASEAN MRA ON GMP INSPECTIONHarmonization and standardization of ASEAN Requirement on GMPThe Quality Systemof the inspectorate Policies Standard SOPs

The Code of GMP PracticeCHALLENGES FOR ASEAN MRA ON GMP INSPECTIONHarmonization and standardization of ASEAN Requirement on GMPThe Quality Systemof the inspectoratePIC/S GMP Reporet formatThe GMP InspectionReport

Conclusion : Challenges & OpportunitiesCurrent GMP and ASEAN Harmonized Requirements and Products (ACTD, GL) for RegistrationOpportunity for GLOBAL and REGIONAL CompetitivenessChallenges to accept New Concept & to meet New RequirementsStrengthening ASEAN pharmaceutical industry technical & managerial competencies at regional / international levelRequires consistent COMMITMENT from : Pharmaceutical industry in fulfilling requirement Government in providing direction and regulatory support

Harmonisasi Regulasi Farmasi ASEANMerupakan bagian dari ASEAN Commitment yang ditandatangani Pimpinan ASEAN ada 11 sektor prioritas termasuk kesehatanApa artinya ? Pasar tunggal farmasi di ASEAN Tidak ada barrier baik tarif maupun non tarifPersaingan terbuka industri farmasi di ASEANPemerintah tidak dapat memberi proteksi, MRA GMP inspectionMutu, keamanan dan khasiat

Harmonisasi Regulasi Farmasi ASEANIndonesia pasar terbesar di ASEANMeningkatkan kapabilitasKetangguhan untuk bertahan tidak menjadi tamu di negara sendiriDaya saing untuk meningkatkan pasar terutama di ASEANSekali lagi mutu, keamanan dan khasiat adalah kata kuncinya.

c-GMP/ Current Good Manufacturing Practice

Aspek CPOB yang Dinamis (c-GMP)

UmumSistem Manajemen MutuBangunan, Sarana Penunjang dan PeralatanSistem Penanganan BahanSistem ProduksiSistem Pengemasan dan PenandaanSistem Pengawasan Mutu

PROFIL PENERAPAN C-GMP/CPOB DinamisSumber : Badan POM 2004Peta Penyebaran Industri FarmasiBerdasarkan Lokasi

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ANALISA HASIL AUDIT BADAN POM, 2004

TANTANGAN INDUSTRI FARMASI INDONESIAPeningkatan compliance terhadap persyaratan & standart pharma globalPenerapan 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 dikembangkanPeran Pharmacist ??Kompetensi Pharmacist ??Kurikulum Pendidikan Tinggi Farmasi ??

PROFIL INDUSTRI FARMASI DI INDONESIA1931376455199Sumber : Badan POM 2004Peta Penyebaran Industri Farmasi Berdasarkan Sertifikat CPOB

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KOMPETENSI APOTEKER DI INDUSTRI FARMASI1.Care GiverMemberi pelayanan di industri farmasi dalam bentuk informasi obat, efek samping obat (ESO), informasi analitis mengenai hal-hal yang berhubungan dengan obat dll2 Decision MakerPengambil 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