[{"_1":2,"_132":-5,"_133":-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","c99006e9-7a82-4813-966c-4ffe6515fe0d","regulationData",{"_36":33,"_37":38,"_128":129,"_130":131},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_60":61,"_62":63,"_67":68,"_75":76,"_77":78,"_79":80,"_81":82,"_83":-5,"_84":85,"_86":87,"_88":-5,"_89":90,"_91":92,"_93":94,"_95":96,"_103":104,"_105":106,"_107":108,"_109":110,"_111":112,"_117":118,"_119":120,"_121":122,"_123":124,"_125":-5,"_126":127},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2022 tentang Pedoman Cara Pembuatan Obat yang Baik di Rumah Sakit","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2022","number","12","year","2022","published_date","2022-06-20","effective_date","2022-06-23","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_55":52,"_56":57,"_58":59},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_55":61,"_56":64,"_65":66},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[69,72],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_55":73,"_56":74,"_58":-5},"52ab02bc-b4c7-47db-becc-c90c58185c43","Standar & Pedoman Teknis","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Cara Pembuatan Obat yang Baik di Rumah Sakit","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2022
Peraturan Badan Pengawas Obat dan Makanan NO. 12, BN.2022/No.623, peraturan.go.id: 10 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Cara Pembuatan Obat yang Baik di Rumah Sakit
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 23 Juni 2022. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Badan Pengawas Obat dan Makanan Nomor 34 Tahun 2018 tentang Pedoman Cara Pembuatan Obat yang Baik, sepanjang mengatur mengenai CPOB pada instalasi farmasi Rumah Sakit dan fasilitas yang melakukan pembuatan sediaan radiofarmaka di Rumah Sakit.","scope_and_parties","policy_content","Peraturan ini bertujuan untuk menjamin mutu obat yang dibuat di rumah sakit dengan mengatur cara pembuatan obat yang baik. Pedoman ini menggantikan pengaturan sebelumnya dan menyesuaikan dengan kebutuhan hukum untuk meningkatkan efektivitas, efisiensi, dan optimalisasi penerapan cara pembuatan obat yang baik di rumah sakit. Pedoman ini mencakup sistem pemastian mutu, personalia, bangunan dan fasilitas, dokumentasi, produksi, pengawasan mutu, pembuatan berdasarkan kontrak, penanganan keluhan dan penarikan kembali produk, inspeksi diri/audit internal, serta cara pembuatan radiofarmaka yang baik di rumah sakit. Rumah sakit wajib menerapkan pedoman ini dan membuktikannya dengan Sertifikat CPOB yang diterbitkan oleh Kepala Badan Pengawas Obat dan Makanan.","transitional_provisions","(-)","sanctions","1. Pelanggaran terhadap pedoman ini dapat dikenakan sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan, pembekuan Sertifikat CPOB, dan/atau pencabutan Sertifikat CPOB.","revokes",[97],{"_98":99,"_100":101,"_36":102},"text","Peraturan BPOM No. 18 Tahun 2022 tentang Pedoman Cara Pembuatan Obat yang Baik di Sarana Pengolahan Produk Berbasis Sel dan Jaringan Manusia","link","https://peraturan.bpk.go.id/Details/223982/peraturan-bpom-no-18-tahun-2022","1bc96330-8c55-4b29-87a2-4ff0c59d7de7","revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[113],{"_98":114,"_100":115,"_36":116},"Peraturan BPOM No. 17 Tahun 2024 tentang Perubahan atas Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2022 tentang Pedoman Cara Pembuatan Obat yang Baik di Rumah Sakit","https://peraturan.bpk.go.id/Details/302520/peraturan-bpom-no-17-tahun-2024","e5400339-6152-47c1-8d4b-98afc856bd9d","partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 12 OF 2022
ON
GUIDELINES FOR GOOD MEDICINE MANUFACTURING IN HOSPITALS

WITH THE BLESSINGS OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

Considering :

that in order to guarantee and ensure the quality of medicines made in hospitals, it is necessary to regulate good medicine manufacturing practices in hospitals;
that the regulation of good medicine manufacturing practices in hospital pharmacy installations and facilities that manufacture radiopharmaceutical preparations as regulated in the Regulation of the Food and Drug Supervisory Agency Number 34 of 2018 concerning Guidelines for Good Medicine Manufacturing, needs to be adapted to legal needs in order to increase the effectiveness, efficiency, and optimization of the application of good medicine manufacturing practices in hospitals so that separate arrangements are

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