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"Pedagang Besar farmasi 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. PBF Cabang adalah cabang PBF yang telah memiliki pengakuan untuk melakukan pengadaan, penyimpanan, penyaluran obat, dan /atau bahan obat dalam jumlah besar sesuai ketentuan perundang-undangan (Kemenkes RI, 2011). Kimia Farma Trading and Distribution (KFTD) merupakan anak perusahaan dari PT Kimia Farma yang bergerak di bidang layanan distribusi dan perdagangan produk Kesehatan di seluruh Indonesia. KFTD mendistribusikan obat, alat kesehatan, dan kosmetik kepada pelanggan sesuai perundang-undangan meliputi rumah sakit, klinik, PBF lain, apotek, dan toko obat. Alur distribusi barang di KFTD berawal sejak barang diproduksi di produsen. Barang-barang yang diproduksi kemudian disimpan di NDC, setelah itu barang akan disalurkan ke KFTD Cabang Jakarta 2 yang nantinya akan disalurkan ke pelanggan. Barang-barang yang diterima di KFTD cabang akan masuk melalui transito in gudang. Penanggungjawab logistik akan memeriksa kesesuaian barang yang datang dengan faktur yang sampai. Hal-hal yang diperiksa diantaranya adalah pengirim, jenis barang, jumlah barang, ED barang dan nomor bets barang yang dipesan. Setelah pemeriksaan selesai dan barang yang diterima sesuai maka selanjutnya stok barang akan dimasukkan ke dalam sistem. Setelah stok di sistem telah diperbarui, maka barang akan masuk ke bagian gudang yang telah ditentukan. Berikut merupakan skema pendistribusian barang di KFTD Jakarta 2 Kegiatan alur distribusi di PBF KFTD Cabang Jakarta 2 dari penerimaan barang hingga pelaporan barang sudah sesuai dengan perundang-undangan yang berlaku.

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Pharmaceutical Wholesalers are companies in the form of legal entities that have permits to procure, store, distribute drugs and/or drug substances in large quantities in accordance with statutory provisions. PBF Branch is a PBF branch that has the recognition to procure, store, distribute drugs and/or drug substances in large quantities in accordance with statutory provisions (Ministry of Health RI, 2011). Kimia Farma Trading and Distribution (KFTD) is a subsidiary of PT Kimia Farma which is engaged in the distribution and trading services of health products throughout Indonesia. KFTD distributes drugs, medical devices and cosmetics to customers in accordance with laws and regulations, including hospitals, clinics, other PBFs, pharmacies and drugstores. The distribution flow of goods at KFTD begins when goods are produced at the manufacturer. The goods produced are then stored at the NDC, after which the goods will be distributed to KFTD Jakarta 2 Branch which will later be distributed to customers. Goods received at the KFTD branch will enter through transit in the warehouse. The person in charge of logistics will check the conformity of the incoming goods with the invoice that arrives. The things examined include the sender, type of goods, quantity of goods, ED of goods and batch number of goods ordered. After the inspection is complete and the goods received are appropriate, then the stock of goods will be entered into the system. After the stock in the system has been updated, the goods will enter the specified warehouse section. The following is a scheme for distributing goods at KFTD Jakarta 2 Distribution channel activities at PBF KFTD Jakarta Branch 2 from receiving goods to reporting goods are in accordance with applicable laws and regulations."

"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.

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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."

"Penyimpanan termasuk ke dalam salah satu dari sembilan aspek CDOB yaitu operasional. Penyimpanan yang tidak tepat atau tidak efektif membuat obat kedaluwarsa tidak terdeteksi dan dapat merugikan rumah sakit, apotek, dan perusahaan besar farmasi. Salah satu obat yang membutuhkan kondisi penyimpanan khusus adalah produk rantai dingin. Suhu penyimpanan merupakan salah satu parameter kritis pada penyimpanan sediaan CCP (Cold Chain Product), hal ini merupakan faktor yang sangat berpengaruh pada kestabilan obat untuk mempertahankan atau menjaga khasiat, mutu dan efikasi. Data yang digunakan diperoleh dari penelusuran pustaka, wawancara, dan observasi terhadap kondisi gudang PT. Kimia Farma Trading & Distribution cabang Jakarta 2. Penelusuran pustaka diperoleh dari peraturan perundang-undangan yang berlaku tentang cara distribusi obat yang baik dan pedagang besar farmasi. Sistem penyimpanan cold chain produk di PT Kimia Farma Trading & Distribution cabang Jakarta 2 mayoritas telah sesuai dengan CDOB. Kata Kunci : Penyimpanan, Produk Rantai Dingin, Cara Distribusi Obat yang Baik dan Benar.

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Storage is included in one of the nine aspects of CDOB, namely operations. Improper or ineffective storage allows expired medications to go undetected and can be detrimental to hospitals, pharmacies, and large pharmaceutical companies. One drug that requires special storage conditions is cold chain products. Storage temperature is one of the critical parameters in storing CCP (Cold Chain Product) preparations, this is a factor that greatly influences the stability of the drug to maintain or maintain efficacy, quality and efficacy. The data used was obtained from literature searches, interviews, and observations of PT warehouse conditions. Kimia Farma Trading & Distribution Jakarta branch 2. The literature search was obtained from applicable laws and regulations regarding proper distribution of medicines and pharmaceutical wholesalers. The majority of product cold chain storage systems at PT Kimia Farma Trading & Distribution, Jakarta 2 branch are in accordance with CDOB."

"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.

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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."

"CDOB/Cara Distribusi Obat yang Baik merupakan pedoman yang digunakan dalam melaksanakan seluruh proses distribusi obat atau bahan obat yang dilakukan oleh PBF/Distributor. Beberapa aspek penting sebagai rantai utama proses distribusi diantaranya yaitu bangunan dan peralatan serta operasional. Kedua aspek tersebut harus dipastikan berjalan sesuai agar proses distribusi dapat berjalan dengan baik. Penelitian ini bertujuan untuk mengidentifikasi kesesuaian penerapan CDOB pada proses distribusi di Kimia Farma Trading and Distribution Cabang Jakarta I. Pengambilan data dilakukan dengan melihat berkas SOP dan tanya jawab dengan karyawan di bagian gudang. Berdasarkan pengamatan tersebut, dapat disimpulkan bahwa Kimia Farma Trading and Distribution Cabang Jakarta I sudah menerapkan CDOB dengan baik di seluruh prosesnya.

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Good Distribution Practices (CDOB/Cara Distribusi Obat yang Baik) are guidelines used to execute the entire drug distribution process conducted by PBF/Distributors. Key aspects of this primary distribution chain include facilities, equipment, and operations. It is crucial to ensure that both aspects function properly to facilitate smooth distribution processes.This study aims to identify the compliance of CDOB implementation in the distribution process at Kimia Farma Trading and Distribution Branch Jakarta I. Data collection involved reviewing SOP documents and conducting interviews with warehouse personnel. Based on these observations, it can be concluded that Kimia Farma Trading and Distribution Branch Jakarta I has effectively implemented CDOB throughout its processes."

"Pedagang Besar Farmasi merupakan perusahaan berbentuk badan hukum yang memiliki izin untuk melakukan pengadaan, penyimpanan, penyaluran obat dan/ atau bahan obat dalam jumlah besar sesuai ketentuan peraturan perundangundangan. Pedoman cara distribusi obat yang baik dalam setiap aspek CDOB (Cara Distribusi Obat yang Baik) perlu diterapkan untuk memenuhi persyaratan mutu, keamanan, serta khasiat obat dan/ atau bahan obat yang didistribusikan. Tugas khusus ini dilakukan menggunakan metode kualitatif dengan studi literatur untuk mengevaluasi pelaksanaan CDOB terhadap proses distribusi di KFTD cabang Jakarta 2. Hasil yang didapat menunjukkan bahwa kegiatan distribusi di KFTD cabang Jakarta 2 sudah sesuai dengan peraturan CDOB. Ketidakefektifan yang ditemukan dalam proses distribusi di KFTD cabang Jakarta 2 berupa proses mengangkut barang yang masih dilakukan dalam posisi tubuh yang salah sehingga dapat menimbulkan bahaya ergonomis berupa sakit pada anggota tubuh personil yang bertugas, juga higiene di KFTD cabang Jakarta 2 yang belum sepenuhnya dilakukan sehingga dapat menimbulkan bahaya biologi di sekitar lingkungan gudang. Evaluasi yang memadai perlu dilakukan terhadap proses pengangkutan barang serta pelatihan terkait posisi tubuh yang benar saat mengangkut barang bagi personil yang bertugas, juga perlu dilakukan permbersihan yang menyeluruh pada gudang untuk menghindari bahaya biologi dari debu berlebih dan/ atau sumber hama lainnya.

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Pharmaceutical Wholesalers is a company in the form of a legal entity that has a permit to procure, store, distribute drugs and/or medicinal substances in large quantities in accordance with statutory provisions. Guidelines for good drug distribution methods in every aspect of CDOB/GDP (Good Distribution Practice) need to be implemented to meet the requirements for quality, safety and efficacy of drugs and/or medicinal substances being distributed. This special assignment was carried out using a qualitative method with literature studies for evaluating the implementation of CDOB for the distribution process at KFTD Jakarta branch 2. The results obtained indicated that the distribution activities at KFTD Jakarta branch 2 complied with CDOB regulations. The ineffectiveness found in the distribution process at KFTD Jakarta branch 2 was in the form of the process of transporting goods which was still carried out in the wrong body position so that it could cause ergonomic hazards in the form of pain in the limbs of the personnel on duty, also hygiene at KFTD Jakarta branch 2 which has not been fully implemented so that it can cause biological hazards around the warehouse environment. Adequate evaluation needs to be carried out on the process of transporting goods as well as training regarding the correct body position when transporting goods for the personnel on duty, it is also necessary to carry out a thorough cleaning of the warehouse to avoid biological hazards from excess dust and/or other sources of pests."

"Pedagang Besar Farmasi merupakan perusahaan berbentuk badan hukum yang memiliki izin untuk pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar sesuai ketentuan peraturan perundang-undangan. Pengadaan, penerimaan, penyimpanan, dan distribusi merupakan salah satu kegiatan operational PBF. PBF wajib menerapkan prinsip-prinsip Cara Distribusi Obat yang Baik. Pelakasanaan operasional PBF dimulai dengan mengkualifikasikan pemasok untuk pengadaan, selanjutnya barang yang diadakan dilakukan penerimaan, penyimpanan, dan distribusi kepada pelanggan yang memenuhi kualifikasi. Semua proses yang berjalan di KFTD mengikuti standar operasional yang dibuat oleh perusahaan, dan disesuaikan dengan petunjuk pelaksanaan teknis CDOB.

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Pharmaceutical Wholesalers are companies in the form of legal entities that have permits to procure, store, distribute medicines and/or medicinal substances in large quantities in accordance with the provisions of statutory regulations. Procurement, receipt, storage and distribution are one of PBF's operational activities. PBF is obliged to apply the principles of Good Medicine Distribution Methods. Implementation of PBF operations begins with qualifying suppliers for procurement, then the goods procured are received, stored and distributed to customers who meet the qualifications. All processes running at KFTD follow operational standards created by the company, and are adapted to GMDM technical implementation instructions."

"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.

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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."

"ABSTRAKLatar belakang/ Tujuan Pedagang Besar Farmasi sebagai penyimpan dan penyalur sediaan farmasi adalah layaknya sebuah perusahaan yang wajib memiliki tenaga penjualan dengan kemampuan dan sumber daya yang unggul sehingga performa perusahaan dapat berjalan dengan baik dalam menghadapi persaingan ketat dan dinamika pasar. Efisiensi dan efektivitas dari proses penjualan yang terorganisir dapat membantu meningkatkan kepuasan pelanggan dan efisiensi operasional dalam rantai pasok produk sediaan farmasi. Dalam rangka menjalankan kegiatan usahanya, sebuah pedagang besar farmasi juga harus menerapkan Cara Distribusi Obat yang Baik (CDOB). Metoda Penelusuran berbagai literatur dari berbagai jurnal, website, dan Prosedur Operasional Standar (SOP) perusahaan, serta wawancara dengan beberapa staf divisi penjualan KFTD Bogor. Hasil Proses usaha di KFTD Bogor ditopang oleh 3 pilar, yaitu: penjualan, logistik, dan keuangan; yang mana divisi penjualan di KFTD Bogor dibagi menjadi divisi penjualan institusi dan reguler. Kesimpulan Divisi penjualan di KFTD Bogor dengan struktur organisasi yang jelas telah memenuhi standar CDOB serta dapat bekerja secara efektif dan efisien.

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ABSTRACTBackground/ Aims Pharmaceutical Wholesalers, as the custodians and distributors of pharmaceutical products, operate much like a company that must have a proficient sales force with exceptional abilities and resources to ensure the company’s performance thrives in the face of intense competition and market dynamics. The efficiency and effectiveness of an organized sales process can contribute to increased customer satisfaction and operational efficiency in the pharmaceutical supply chain. To carry out their business activities, a pharmaceutical wholesaler must also adhere to Good Distribution Practice (GDP) guidelines Methods The research methodology involved exploring various literature from journals, websites, and the company’s Standard Operating Procedures (SOPs), as well as conducting interviews with several staff members from the sales division of KFTD Bogor. Results The business process at KFTD Bogor is supported by three pillars: sales, logistics, and finance. The sales division of KFTD Bogor is further divided into institutional and regular sales divisions. Conclusion The sales division at KFTD Bogor, with a clear organizational structure, has met GDP standards and can operate effectively and efficiently."

"Dokumentasi di Pedagang Besar Farmasi (PBF) merupakan salah satu bagian penting dari sistem manajemen mutu yang diatur dalam Cara Distribusi Obat yang Baik (CDOB). Kegiatan dokumentasi bertujuan untuk menjamin pelaksanaan distribusi berjalan sesuai dengan panduan mutu serta peraturan perundang-undangan yang berlaku. PT Kimia Farma Trading & Distribution (KFTD) merupakan anak perusahaan dari PT Kimia Farma Tbk. yang bergerak di bidang pelayanan distribusi dan perdagangan produk-produk farmasi, Cold Chain Product (CCPs), alat kesehatan, hingga kosmetik. Penelitian ini bertujuan untuk menilai kesesuaian surat pesanan dan faktur sebagai bentuk dokumentasi kegiatan yang berjalan di Kimia Farma Trading and Distribution Cabang Jakarta 2 berdasarkan CDOB. Kelengkapan yang dinilai mencakup aspek identitas penanggung jawab sarana pemesan, identitas dan legalitas sarana pemesan, identitas PBF, identitas surat pesanan dan faktur, serta identitas produk pesanan. Berdasarkan hasil penelitian diketahui bahwa dari 20 surat pesanan yang dievaluasi belum ada yang memenuhi syarat kelengkapan secara sempurna, sementara untuk evaluasi faktur terdapat 14 faktur yang memenuhi kelengkapan dari 20 faktur yang dievaluasi.

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Documentation at Pharmaceutical Wholesalers is an important part of the quality management system regulated in Good Distribution Practice (GDP). Documentation activities aim to ensure that the implementation of the distribution goes according to the quality guidelines and applicable laws and regulations. PT Kimia Farma Trading & Distribution (KFTD) is a subsidiary of PT Kimia Farma Tbk. which is engaged in the distribution and trading services of pharmaceutical products, Cold Chain Products (CCPs), medical devices, and cosmetics. This study aims to assess the suitability of orders and invoices as a form of reporting on ongoing activities at Kimia Farma Trading and Distribution Branch Jakarta 2 based on GDP. Completeness assessed includes aspects of the identity of the person in charge of the health facility, identity and legality of the health facility, Pharmaceutical Wholesaler identity, identity of order letters and invoices, and identity of ordered products. Based on the research results, it is known that of the 20 evaluated order letters, none of them fulfilled the completeness requirements perfectly, while for invoice evaluation, there were 14 invoices that fulfilled the completeness of the 20 evaluated invoices."