[{"_1":2,"_133":-5,"_134":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","en","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","fdd4077d-e43a-41f4-acd0-30c2c2f72b7c","regulationData",{"_36":33,"_37":38,"_129":130,"_131":132},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":48,"_50":51,"_52":53,"_59":60,"_61":62,"_66":67,"_77":78,"_79":80,"_81":82,"_83":84,"_85":-5,"_86":87,"_88":89,"_90":-5,"_91":92,"_93":94,"_95":96,"_97":98,"_104":105,"_110":111,"_112":113,"_114":115,"_116":117,"_118":119,"_120":121,"_122":123,"_124":125,"_126":-5,"_127":128},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 34 Tahun 2018 tentang Pedoman Cara Pembuatan Obat yang Baik","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 34 Tahun 2018","number","34","year","2018","published_date","2018-12-07","effective_date","status_id","89192b77-602e-484c-89df-4fd3166b732a","status",{"_54":51,"_55":56,"_57":58},"id","name","Tidak Berlaku","description","Peraturan yang sudah tidak berlaku karena dicabut, diubah, atau habis masa berlakunya","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_54":60,"_55":63,"_64":65},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[68,71,74],{"_54":69,"_55":70,"_57":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_54":72,"_55":73,"_57":-5},"52ab02bc-b4c7-47db-becc-c90c58185c43","Standar & Pedoman Teknis",{"_54":75,"_55":76,"_57":-5},"ba8e8363-834f-45d3-85f2-9308c4bc5c62","Hak & Perlindungan Konsumen","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Cara Pembuatan Obat yang Baik","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2018
Peraturan Badan Pengawas Obat dan Makanan NO. 34, BN.2018/No.1600, jdih.pom.go.id: 6 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Cara Pembuatan Obat yang Baik
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 07 Desember 2018. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor ΗΚ.03.1.33.12.12.8195 Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik sebagaimana telah diubah dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2018.","scope_and_parties","policy_content","

Peraturan ini bertujuan untuk menyesuaikan Pedoman Cara Pembuatan Obat yang Baik (CPOB) dengan perkembangan ilmu pengetahuan dan teknologi di bidang pembuatan obat dan bahan obat. CPOB adalah cara pembuatan obat dan/atau bahan obat yang bertujuan untuk memastikan mutu obat dan/atau bahan obat yang dihasilkan sesuai dengan persyaratan dan tujuan penggunaan. Pedoman ini wajib menjadi acuan bagi industri farmasi dan sarana yang melakukan kegiatan pembuatan obat dan bahan obat. Pedoman CPOB meliputi berbagai aspek seperti sistem mutu industri farmasi, personalia, bangunan-fasilitas, peralatan, produksi, cara penyimpanan dan pengiriman obat yang baik, pengawasan mutu, inspeksi diri, keluhan dan penarikan produk, dokumentasi, kegiatan alih daya, kualifikasi dan validasi, serta pembuatan produk steril. Industri farmasi yang tidak mengikuti acuan Pedoman CPOB dikenai sanksi administratif.

","transitional_provisions","(-)","sanctions","

1. Industri farmasi yang tidak mengikuti acuan Pedoman CPOB dikenai sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan, pembekuan Sertifikat CPOB, pencabutan Sertifikat CPOB, dan/atau rekomendasi pencabutan izin industri farmasi.

","revokes",[99],{"_100":101,"_102":103},"text","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.33.12.12.8195 Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik (Berita Negara Republik Indonesia Tahun 2012 Nomor 122) sebagaimana telah diubah dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2018 tentang Perubahan Keputusan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.33.12.12.8195 Tahun 2012 tentang Penerapan Pedoman Cara Pembuatan Obat yang Baik (Berita Negara Republik Indonesia Tahun 2012 Nomor 985)","link","","revoked_by",[106],{"_100":107,"_102":108,"_36":109},"Peraturan BPOM No. 7 Tahun 2024 tentang Standar Cara Pembuatan Obat yang Baik","https://peraturan.bpk.go.id/Details/286412/peraturan-bpom-no-7-tahun-2024","104762e4-0a6b-4f62-aee1-9aa5ba6f0ae7","partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 34 OF 2018
CONCERNING
GUIDELINES FOR GOOD MEDICINE MANUFACTURING PRACTICE

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that the Guidelines for Good Medicine Manufacturing Practice as stipulated in the Regulation of the Head of the Food and Drug Control Agency Number ΗΚ.03.1.33.12.12.8195 of 2012 concerning the Application of Guidelines for Good Medicine Manufacturing Practice as amended by the Regulation of the Head of the Food and Drug Control Agency Number 13 of 2018 concerning Amendments to the Regulation of the Head of the Food and Drug Control Agency Number HK.03.1.33.12.12.8195 of 2012 concerning the Application of Guidelines for Good Medicine Manufacturing Practice, needs to be adjusted to the development of science and technology in the field of medicine and drug substance manufacturing;

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