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Hasil Pencarian

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Rifa Nadya Syahira
"Inspeksi diri merupakan salah satu prinsip CDOB untuk mengusulkan langkah-langkah perbaikan yang diperlukan. Laporan ini mengevaluasi pelaksanaan inspeksi diri terkait pengelolaan narkotika dan psikotropika di PT Kimia Farma Trading & Distribution (KFTD) Cabang Bogor selama Februari 2024 berdasarkan dokumen formulir inspeksi diri yakni FORM/LOG/QA/077. Inspeksi diri bertujuan untuk memastikan kepatuhan terhadap regulasi sesuai standar Cara Distribusi Obat yang Baik (CDOB) guna menjamin keamanan, khasiat, dan mutu obat. Metode yang digunakan meliputi observasi, wawancara, dan analisis dokumen serta SOP terkait pengadaan, penyimpanan, penyaluran, dan dokumentasi. Hasil evaluasi menunjukkan KFTD Bogor telah memenuhi standar yang ditetapkan Badan POM. Pengelolaan narkotika dan psikotropika dilakukan dengan langkah-langkah yang sistematis dan sesuai peraturan, termasuk pengendalian akses, pemisahan ruang penyimpanan, dan dokumentasi tertib. Namun, formulir inspeksi diri perlu diaudit terlebih dahulu serta diperlukan perbaikan seperti penerapan penyimpanan alfabetis untuk meningkatkan efisiensi pengelolaan. Kesimpulannya, inspeksi diri telah dilaksanakan dengan baik, dan hasilnya menunjukkan tingkat kepatuhan yang tinggi terhadap regulasi yang berlaku, memberikan jaminan pengelolaan yang aman dan bertanggung jawab atas narkotika dan psikotropika di PT Kimia Farma Trading & Distribution (KFTD) Cabang Bogor.

Self-inspection is a key principle of Good Distribution Practices (GDP) to propose necessary improvement measures. This report evaluates the implementation of self-inspection concerning the management of narcotics and psychotropics at PT Kimia Farma Trading & Distribution (KFTD) Bogor Branch in February 2024, based on the self-inspection document FORM/LOG/QA/077. The self-inspection aims to ensure compliance with regulations aligned with GDP standards to guarantee the safety, efficacy, and quality of medicines. Methods included observations, interviews, and analysis of documents and Standard Operating Procedures (SOPs) related to procurement, storage, distribution, and documentation. The evaluation revealed that KFTD Bogor meets the standards set by the National Agency of Drug and Food Control (BPOM). The management of narcotics and psychotropics is conducted systematically and adheres to regulations, including access control, segregated storage, and orderly documentation. However, the self-inspection form requires prior auditing, and improvements such as implementing alphabetical storage are suggested to enhance management efficiency. In conclusion, the self-inspection was effectively executed, demonstrating a high level of regulatory compliance and ensuring safe and accountable management of narcotics and psychotropics at PT Kimia Farma Trading & Distribution (KFTD) Bogor Branch. "
Depok: Fakultas Farmasi Universitas Indonesia, 2024
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Ria Artha Rani
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Pharmaceutical disributor is one of the parties distributing pharmaceutical products including Cold Chain Products (CCP). Kimia Farma Trading & Distribution (KFTD) Jakarta 3 Branch is one of the PBFs that distributes CCP to various health care facilities. Therefore, KFTD Jakarta 3 must have a distribution procedure that can guarantee the stability of the distributed CCP. In order to ensure the ability of the distribution process to maintain product stability, it is necessary to validate the CCP distribution process from KFTD Jakarta 3."
Depok: Fakultas Farmasi Universitas Indonesia, 2022
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Astri Maulinda Sari
"PT KFTD merupakan Pedagang Besar Farmasi yang memiliki izin untuk menyalurkan obat keras golongan narkotika. Evaluasi pemesanan obat golongan narkotika dilakukan berdasarkan ketetapan yang berlaku di PT KFTD. Evaluasi kewajaran jumlah dan frekuensi ini selanjutnya digunakan sebagai acuan bagi apoteker penanggung jawab KFTD dalam melakukan penilaian penerimaan pesanan narkotika dari outlet terkait.Penilaian awal status kewajaran pemesanan dilakukan dengan membandingkan histori pembelian aktual obat Fentanyl (PCC) dari Outlet X selama periode September 2021 – September 2022 kepada PBF KFTD Cabang Bekasi tiap bulannya dengan rata-rata pembelian obat yang didapat dari big data milik PT KFTD.Penjualan obat Fentanyl PCC menempati penjualan tertinggi untuk obat golongan narkotika di PT KFTD Cabang Bekasi, yaitu mencapai 53,265% selama periode September 2021 – September 2022. Penjualan obat Fentanyl dilakukan kepada 90 outlet mitra kerja dengan Outlet X merupakan outlet dengan frekuensi pembelian terbanyak yaitu 2.216 dus @ 5 ampul dalam setahun.Penilaian kewajaran pesanan narkotika yang diterima oleh PBF KFTD Cabang Bekasi harus dilakukan dengan membandingkan riwayat pembelian sebelumnya disertai dengan melakukan kunjungan audit langsung ke outlet mitra kerja terkait.

PT KFTD is a Pharmaceutical Distributor who has a permit to distribute narcotic hard drugs. Evaluation of orders for narcotic class drugs is carried out based on the provisions in force at PT KFTD. The evaluation of the reasonableness of the quantity and frequency is then used as a reference for the pharmacist in charge of the KFTD in assessing the acceptance of narcotics orders from related outlets. The initial assessment of the reasonableness of the order status is carried out by comparing the history of actual purchases of Fentanyl (PCC) drugs from Outlet X during the period September 2021 - September 2022 to PBF KFTD Bekasi Branch each month with an average purchase of drugs obtained from PT KFTD's big data. Sales of Fentanyl PCC drugs occupy the highest sales for narcotic drugs at PT KFTD Bekasi Branch, reaching 53.265% during the period September 2021 - September 2022. Fentanyl drug sales are carried out to 90 partner outlets with Outlet X being the outlet with the highest frequency of purchases, namely 2,216 boxes @ 5 ampoules in a year. An assessment of the fairness of narcotics orders received by PBF KFTD Bekasi Branch must be carried out by comparing the history of previous purchases accompanied by making direct audit visits to related partner outlets."
Depok: Fakultas Farmasi Universitas Indonesia, 2022
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Sandra Febrianti
"Alur keuangan adalah serangkaian kegiatan pencatatan keuangan di perusahaan yang terdiri dari pencatatan, perhitungan, dan kearsipan. Oleh sebab itu, KFTD ditunjang oleh proses bisnis yang saling berkaitan dalam memberikan produk atau layanan kepada pelanggan salah satunya adalah manajemen keuangan. Penyusunan tugas khusus ini bertujuan untuk mengetahui dan memahami pelaksanaan alur keuangan di Kimia Kimia Farma Trading & Distribution Cabang Bogor Periode Juli 2022. Metode yang digunakan berupa study literature penelusuran pustaka seperti pedoman cara distribusi obat yang baik. Laman resmi PT Kimia Farma Trading & Distribution, melakukan wawancara secara lisan dengan penanggung jawab di KFTD Bogor. Sehingga didapatkan kesimpulan bahwa Proses distribusi Obat dan Bahan Obat di PT. Kimia Farma Trading & Distribution Cabang Bogor telah memenuhi aspek Cara Distribusi Obat yang baik. Pencapaian sasaran pada unit tata usaha di PT. KFTD cabang Bogor sudah tercapai dengan baik.

Financial flow is a series of recording activities in a financial company which consists of recording, calculating, and filing. Therefore, KFTD is supported by interrelated business processes in providing products or services to customers, one of which is financial management. The preparation of this special assignment aims to find out and understand the implementation of financial flows at Kimia Farma Trading & Distribution, Bogor Branch for the July 2022 period. The method used is in the form of studying literature search literature such as guidelines for good drug distribution. The official website of PT Kimia Farma Trading & Distribution, conducted an oral interview with the person in charge at KFTD Bogor. So the conclusion is that the process of distributing drugs and materials obtained by drugs at PT. Kimia Farma Trading & Distribution Bogor Branch has fulfilled aspects of good drug distribution methods. Achievement of targets on the administrative unit at PT. KFTD Bogor branch has achieved well."
Depok: 2022
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Lisa Amelia
"Pada CDOB diatur mengenai ketentuan operasional dalam kegiatan distribusi obat. Kegiatan operasional tersebut termasuk ke dalam bagian logistik. Tujuan laporan tugas khusus ini adalah untuk mempelajari serta menganalisis kesesuaian pelaksanaan alur logistik di Kimia Farma Trading and Distribution Cabang Bogor dengan persyaratan CDOB. Metode yang digunakan dalam pengerjaan laporan ini yaitu studi literatur dari berbagai sumber seperti CDOB serta wawancara langsung dengan narasumber Apoteker Penanggung Jawab dan karyawan lain yang bekerja pada KFTD Cabang Bogor. Proses distribusi obat bagian logistik yang dilakukan oleh Kimia Farma Trading and Distribution Cabang Bogor secara umum telah memenuhi persyaratan CDOB, walaupun masih belum sempurna terutama pada bagian penyimpanan karena adanya kendala kapasitas ruangan yang kurang.

The GDP regulates operational provisions in drug distribution activities. These operational activities are included in the logistics section. The purpose of this report is to study and analyze the suitability of the implementation of the logistics flow at Kimia Farma Trading and Distribution Bogor Branch with the GDP requirements. The method used in preparing this report was a literature study from various sources such as GDP and direct interviews with the responsible pharmacist and other employees working at the KFTD Bogor Branch. The drug distribution process in the logistics section carried out by the Kimia Farma Trading and Distribution Bogor Branch in general has met the GDP requirements, although it is still not perfect, especially in the storage section due to insufficient space capacity constraints."
Depok: 2022
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Sandra Febrianti
"Alur keuangan adalah serangkaian kegiatan pencatatan di perusahaan keuangan yang terdiri dari pencatatan, perhitungan, dan kearsipan. Oleh karena itu, KFTD ditunjang oleh proses bisnis yang saling berkaitan dalam memberikan produk atau layanan kepada pelanggan salah satunya adalah manajemen keuangan. Penyusunan tugas khusus ini bertujuan untuk mengetahui dan memahami pelaksanaan alur keuangan di Kimia Farma Trading & Distribution Cabang Bogor Periode Juli 2022. Metode yang digunakan berupa mempelajari literatur penelusuran pustaka seperti pedoman cara pendistribusian obat yang baik. Laman resmi PT Kimia Farma Trading & Distribution, melakukan wawancara secara lisan dengan penanggung jawab di KFTD Bogor. Sehingga kesimpulan bahwa Proses pendistribusian Obat dan Bahan yang diperoleh Obat di PT. Kimia Farma Trading & Distribution Cabang Bogor telah memenuhi aspek Cara Distribusi Obat yang baik. Pencapaian sasaran pada unit tata usaha di PT. KFTD cabang Bogor sudah tercapai dengan baik.

Financial flow is a series of recording activities in a financial company which consists of recording, calculating, and filing. Therefore, KFTD is supported by interrelated business processes in providing products or services to customers, one of which is financial management. The preparation of this special assignment aims to find out and understand the implementation of financial flows at Kimia Farma Trading & Distribution, Bogor Branch for the July 2022 period. The method used is in the form of studying literature search literature such as guidelines for good drug distribution. The official website of PT Kimia Farma Trading & Distribution, conducted an oral interview with the person in charge at KFTD Bogor. So the conclusion is that the process of distributing drugs and materials obtained by drugs at PT. Kimia Farma Trading & Distribution Bogor Branch has fulfilled aspects of good drug distribution methods. Achievement of targets on the administrative unit at PT. KFTD Bogor branch has achieved well."
Depok: Fakultas Farmasi Universitas Indonesia, 2023
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Indra Irsandi Johan
"Dalam melaksanakan fungsinya, pedagang besar farmasi (PBF) harus mengimplementasikan pedoman teknis cara distribusi obat yang baik (CDOB), yang bertujuan untuk memastikan penyaluran dilakukan sesuai dengan persyaratan yang telah ditetapkan. CDOB merupakan standar yang sangat penting dalam upaya mempertahankan mutu dan integritas distribusi obat di setiap rantai distribusi mulai dari industri farmasi hingga fasilitas pelayanan kefarmasian. Dengan demikian, pengawasan pasca pemasaran dalam kerangka penerapan CDOB dimaksudkan untuk memastikan bahwa mutu, khasiat, dan keamanan obat di sepanjang jalur distribusi tetap dipertahankan sesuai dengan karakteristik pada saat obat dimaksud disetujui untuk beredar. Penelitian ini bertujuan untuk mengamati dan memahami kesesuaian penerapan CDOB di Kimia Farma Trading & Distribution cabang Jakarta 2 pada periode 03 Juli – 14 Juli 2023. Pelaksanaan dilakukan dengan studi observasi atau pengamatan langsung di lapangan. Hasil dari pengamatan yang telah dilakukan, dapat diketahui bahwa Kimia Farma Trading & Distribution cabang Jakarta 2 pada periode 3 Juli – 14 Juli 2023 telah menerapkan CDOB sesuai dengan persyaratan yang berlaku.

In carrying out its function, pharmaceutical wholesale traders (PBF) must implement the technical guidelines for Good Distribution Practices (CDOB), which aim to ensure that distribution is carried out in accordance with established requirements. CDOB is a very important standard in maintaining the quality and integrity of drug distribution in every distribution chain from the pharmaceutical industry to pharmaceutical service facilities. Therefore, post-marketing supervision within the framework of implementing CDOB is intended to ensure that the quality, efficacy, and safety of drugs along the distribution chain are maintained in accordance with the characteristics when the drug was approved for circulation. This study aims to observe and understand the suitability of CDOB implementation at Kimia Farma Trading & Distribution Branch Jakarta 2 from July 3 to July 14, 2023. The implementation was conducted through observation studies or direct field observations. Based on the observations conducted, it can be concluded that Kimia Farma Trading & Distribution Branch Jakarta 2 during the period of July 3 to July 14, 2023, has implemented CDOB in accordance with applicable requirements."
Depok: Fakultas Farmasi Universitas ndonesia, 2023
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Chrisandy Ramadhanti
"Vaksin merupakan unsur biologis yang memiliki karakteristik khusus dan sensitif terhadap temperatur, vaksin rentan mengalami penurunan mutu dan efektivitas apabila terpapar oleh temperatur yang tidak sesuai dengan karakteristik temperatur penyimpanan yang telah dipersyaratkan. Upaya dalam menjaga mutu dan efektivitas vaksin tidak semata-mata hanya ditentukan dari cara vaksin diproduksi dengan baik dan benar, tetapi salah satu urgensi yang dapat menjadi titik kritis penentuan mutu dan efektivitas vaksin yaitu perlakuan selama proses pengelolaan. PBF berperan penting dalam mengelola vaksin mulai dari penerimaan, penyimpanan hingga pendistribusian vaksin ke berbagai fasilitas kesehatan. Sebelum vaksin didistribusikan, vaksin akan melalui proses penyimpanan pada alat berupa chiller. Selama proses penyimpanan, perlu dilakukan pemantauan suhu vaksin secara berkala. Pemantauan suhu secara berkala berkaitan erat dengan alat yang digunakan selama proses penyimpanan vaksin yaitu chiller. Penggunaan chiller sebagai alat penyimpanan vaksin harus melalui tahap validasi sesuai persyaratan yang telah ditetapkan yaitu dapat mempertahankan suhu penyimpanan antara 2-8°C. Hal ini bertujuan sebagai acuan standar operasional selama proses penyimpanan vaksin berlangsung. Melalui tugas khusus ini dapat diketahui bahwa chiller yang digunakan selama proses penyimpanan produk vaksin di PT. Kimia Farma Trading & Distribution Cabang Jakarta 1 telah valid dan mampu mempertahankan kestabilan suhu pada rentang 2-8°C selama jangka waktu ± 20 jam bahkan lebih apabila chiller dalam kondisi dinyalakan.

Vaccines are biological elements that have special characteristics and are sensitive to temperature, vaccines are prone to decreasing quality and effectiveness when exposed to temperatures that do not match the required storage temperature characteristics. Efforts to maintain vaccine quality and effectiveness are not solely determined by how vaccines are produced properly and correctly, but one of the urgency that can become a critical point in determining vaccine quality and effectiveness, namely treatment during the management process. PBF plays an important role in managing vaccines from receipt, storage to distribution of vaccines to various health facilities. Before the vaccine is distributed, the vaccine will go through a storage process in a chiller. During the storage process, it is necessary to periodically monitor the temperature of the vaccine. Periodic temperature monitoring is closely related to the equipment used during the vaccine storage process, namely the chiller. The use of a chiller as a vaccine storage device must go through a validation stage according to predetermined requirements, namely being able to maintain a storage temperature between 2-8°C. This is intended as a reference for operational standards during the vaccine storage process. Through this special assignment, it can be seen that the chiller used during the process of storing vaccine products at PT. Kimia Farma Trading & Distribution Jakarta Branch 1 is valid and able to maintain temperature stability in the range of 2-8°C for a period of ± 20 hours or more if the chiller is turned on."
Depok: 2022
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Melia Fajar Hasanah
"Pedagang Besar Farmasi (PBF) adalah perusahaan berbentuk badan hukum yang memiliki izin untuk pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar sesuai ketentuan peraturan perundang-undangan. Karena PBF merupakan salah satu dari mata rantau alur distribusi, dalam menyelenggarakan pengadaan, penyimpanan, dan penyaluran obat dan/atau bahan obat, PBF wajib menerapkan Pedoman Teknis Cara Distribusi Obat yang Baik (CDOB). Cara Distribusi Obat yang Baik (CDOB) adalah cara distribusi atau penyaluran obat dan/atau bahan obat yang bertujuan untuk memastikan mutu sepanjang jalur distribusi sesuai persyaratan dan tujuan penggunaannya. Perlu adanya pemahaman tentang peran apoteker di PBF sehingga dapat meningkatkan fungsi dan peran apoteker dalam mengendalikan dan mengawasi distribusi obat dan alat kesehatan. Pelaksanaan evaluasi alur penerimaan produk rantai dingin dan narkotika dilakukan dengan membandingkan SOP dan aktual di lapangan serta CDOB. Analisis dilakukan dengan membandingkan kesesuaian SOP dan alur penerimaan aktual di lapangan untuk produk rantai dingin dan narkotika KFTD Cabang Bogor dengan CDOB (Cara Distribusi Obat yang Baik) serta melakukan evaluasi terhadap SOP penerimaan serta alur penerimaan aktual di lapangan untuk produk rantai dingin dan narkotika berdasarkan ketentuan CDOB. Berdasarkan hasil pengamatan alur penerimaan CCP atau narkotika di KFTD cabang Bogor, baik Standar Operasional Prosedur Kimia Farma Trading and Distribution serta kegiatan penerimaannya di lapangan telah sesuai dengan Pedoman Cara Distribusi Obat yang Baik.

Pharmaceutical Supplier (PBF) are companies in the form of legal entities that have permits to procure, store, distribute drugs and/or medicinal ingredients in large quantities in accordance with statutory provisions. Because PBF is one of the distribution flow links, in organizing the procurement, storage and distribution of drugs and/or medicinal ingredients, PBF is obliged to implement the Technical Guidelines for Good Drug Distribution Methods (CDOB). Good Medicine Distribution Method (CDOB) is a method of distributing or distributing medicines and/or medicinal substances which aims to ensure quality along the distribution route according to the requirements and intended use. There needs to be an understanding of the role of pharmacists in PBF so that they can improve the function and role of pharmacists in controlling and supervising the distribution of medicines and medical devices. Evaluation of the flow of receipt of cold chain products and narcotics is carried out by comparing SOPs and actuals in the field and CDOB. The analysis was carried out by comparing the suitability of the SOP and actual receipt flow in the field for cold chain and narcotic products of KFTD Bogor Branch with CDOB (Good Medicine Distribution Method) as well as evaluating the receipt SOP and actual receipt flow in the field for cold chain and narcotic products based on the provisions CDOB. Based on the results of observations of the flow of CCP or narcotics receipts at KFTD Bogor branch, both Kimia Farma Trading and Distribution Standard Operational Procedures as well as receipt activities in the field are in accordance with the Guidelines for Good Drug Distribution Methods."
Depok: Fakultas Farmasi Universitas ndonesia, 2022
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Anisa Qisti Mathriul
"Kimia Farma Trading and Distribution Bogor branch is a PBF branch of Pt Kimia Farma Tbk which engaged in distribution, including narcotics. Provisions related to the procurement, receipt and distribution of Narcotics are regulated in such a way in statutory regulations. This is intended so that the distribution of narcotics in the community can be controlled and the risk of drug abuse can be minimized. This report will discuss the flow of distribution of narcotics at Kimia Farma Trading & Distribution Bogor branch. This report was prepared based on a literature search of standard operating procedures (SOP) that apply at KFTD, regulations and interviews with the pharmacist in charge at the KFTD Bogor branch office. The results of the report show that the distribution of narcotics at the KFTD Bogor branch includes procurement, receipt, packaging and distribution of narcotic. This activity has been carried out in accordance with SOP, CDOB guidelines and Permenkes Number 3 of 2015.

Kimia Farma Trading and Distribution Bogor branch is a PBF branch of Pt Kimia Farma Tbk which engaged in distribution, including narcotics. Provisions related to the procurement, receipt and distribution of Narcotics are regulated in such a way in statutory regulations. This is intended so that the distribution of narcotics in the community can be controlled and the risk of drug abuse can be minimized. This report will discuss the flow of distribution of narcotics at Kimia Farma Trading & Distribution Bogor branch. This report was prepared based on a literature search of standard operating procedures (SOP) that apply at KFTD, regulations and interviews with the pharmacist in charge at the KFTD Bogor branch office. The results of the report show that the distribution of narcotics at the KFTD Bogor branch includes procurement, receipt, packaging and distribution of narcotic. This activity has been carried out in accordance with SOP, CDOB guidelines and Permenkes Number 3 of 2015."
Depok: Fakultas Farmasi Universitas ndonesia, 2022
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