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"Sistem mutu yang konsisten wajib ada pada Pedagang Besar Farmasi (PBFagar perbekalan farmasi yang disalurkan terjamin keamanan, khasiat, dan mutunya. Usaha yang dapat dilakukan PBF dalam menjaga mutu perbekalan farmasi adalah dengan menerapkan dua aspek dalam CDOB. Aspek pertama adalah Aspek Inspeksi Diri dan yang kedua adalah Aspek Keluhan, Obat dan/atau Bahan Obat Kembalian, Diduga Palsu dan Penarikan Kembali yang terdapat dalam pedoman teknis Cara Distribusi Obat yang Baik (CDOB). Bagaimana kedua aspek tersebut diterapkan oleh PBF PT. Masiva Guna selama rangkaian proses distribusi berlangsung menjadi tema dalam penelitian ini. Penelitian ini bersifat observasional dengan tahap pelaksanaan: observasi pada kegiatan harian PBF; wawancara dengan Apoteker Penanggung Jawab (APJ), supervisor, serta staf; dan studi literatur. Hasilnya, aspek pertama dilakukan melaui audit internal dan audit mutu setiap enam bulan. audit mutu dilakukan oleh pihak eksternal yaitu dinas Kesehatan, sedangkan inspeksi diri dilakukan oleh tim audit internal. APJ berperan untuk memastikan terlaksananya audit. Inspeksi diri dilakukan dengan mengecek pemenuhan persyaratan pada form daftar periksa yang telah disusun APJ berdasarkan daftar periksa dari Badan POM dan hal yang akan berpengaruh pada untung dan rugi perusahaan. Aspek Kedua dilakukan melalui service level (Serlev) untuk menangani keluhan dengan segera dan menyediakan prosedur tertulis untuk penanganan dan penerimaan obat dan/atau bahan obat kembalian. Penerapan aspek inspeksi diri dan aspek keluhan, Obat dan/atau Bahan Obat kembalian, diduga palsu dan penarikan Kembali pada PBF PT. Masiva Guna telah sesuai dengan CDOB.

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A consistent quality system must be own by Pharmaceutical Wholesalers (PBF) so that the safety, efficacy and quality of the pharmaceutical supplies are guaranteed. Efforts that PBF can make to maintain the quality of pharmaceutical supplies are by implementing two aspects of Good Distribution Practices (GDP). The first aspect is the Self-Inspection and the second is the Aspect of Complaints, Returned Medicines and/or Medicinal Ingredients, Suspected of being Counterfeit and Recalls which are contained in the technical guidelines of GDP. How these two aspects are implemented by PBF PT. Masiva Guna during the series of distribution processes is the theme of this research. This research is observational. the implementation stages are: observation of PBF's activities; interviews with the Pharmacist in Charge, supervisors and staff; and literature study. As a result, the first aspect is carried out through internal audits and quality audits every six months. Quality audits are carried out by external parties (Health Service), while self-inspections are carried out by the internal audit team. APJ plays role in ensuring the implementation of the audit. Self-inspection is carried out by checking the fulfillment of the requirements on the checklist form prepared by APJ based on the checklist from the BPOM and matters that will affect the company's profits and losses. The second aspect is carried out through the service level program to handle complaints immediately and provide written procedures for handling and receiving returned medicines and/or medicinal substances. Implementation of both aspects at PBF PT. Masiva Guna is GDP compliant."

"ABSTRAKPraktik kerja profesi di PT Kimia Farma Trading And Distribution Cabang Jakarta 1 Bulan Oktober Tahun 2018 bertujuan untuk mampu memahami peranan, tugas dan tanggung jawab apoteker di Distributor/Pedagang Besar Farmasi (PBF) sebagai apoteker penanggung jawab, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di distributor farmasi, memahami penerapan GDP/CDOB di distributor farmasi, dan memiliki gambaran nyata tentang permasalahan-permasalahan pekerjaan kefarmasian di distributor farmasi. Praktik kerja profesi ini dilakukan selama 12 hari dengan tugas khusus Analisis Inspeksi Diri Dalam Aspek Pengadaan dan Penyaluran Pada PT Kimia Farma Trading and Distribution Cabang Jakarta 1 bertujuan untuk mengetahui inspeksi diri yang dilakukan oleh PBF PT. Kimia Farma Trading and Distribution cabang Bogor untuk memastikan proses distribusi berjalan dengan baik sesuai dengan aturan CDOB.

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ABSTRACTInternship at PT Kimia Farma Trading and Distribution Jakarta Branch Period September 2018 aims to understand the role, duties and responsibilities of pharmacists in Pharmaceutical Wholesalers / Distributors (PBF) as responsible pharmacists, have insight, knowledge, skills, and practical experience to do pharmaceutical work at pharmaceutical distributors, understand the application of GDP / CDOB in pharmaceutical distributors, and has a real picture of the problems of pharmaceutical work at pharmaceutical distributors. The internship are carried out for 12 days with a special task Analysis of Self-Inspection in the Procurement and Distribution Aspects of PT Kimia Farma Trading and Distribution Jakarta 1 Branch aimed at finding out the self-inspections conducted by PBF PT. Kimia Farma Trading and Distribution Jakarta branch to ensure the distribution process runs well in accordance with CDOB rules."

"ABSTRAKApoteker di industri farmasi memiliki tanggung profesi untuk memastikan bahwa mutu obat yang dihasilkan memenuhi persyaratan dan tujuan penggunaannya dengan berpedoman kepada prinsip Cara Pembuatan Obat yang Baik (CPOB).Kegiatan Praktek Kerja Profesi Apoteker (PKPA) ditujukan untuk memberikan pengalaman praktis dan gambaran nyata mengenai peran,tugas dan tanggung jawab profesi apoteker di industri farmasi.PKPA ini dilaksanakan di PT. AstraZeneca Indonesia selama dua bulan di bagian pemastian mutu dengan kegiatan utama berupa induksi materi dari berbagai departemen, mengerjakan Annual Product Review (APR), mengerjakan Corrective Action Preventive Action (CAPA) dan evidence based dari self inspection serta mengerjakan gap analysis prosedur.Induksi yang diberikan berupa penjelasan singkat mengenai tugas dan fungsi dari masing-masing departemen.APR yang dikerjakan berupa dua APR dari produk packing I MY, I TW dan I AU serta satu APR dari produk repacking Z dan B.Hasilnya, semua produk packing maupun repacking dinyatakan rilis.Penerapan CAPA dan evidence based terhadap self inspection documentation error dilakukan dengan memberikan SOP ke bagian departemen yang belum tedaftar sebelumnya.Sedangkan gap analysis dari guidline Process Trending and Robustness Analysis dengan SOP Product Review Report dan Standart Change Control in the Quality and Compliance Area serta SOP Operations Change Management dengan SOP Change Management masih memberikan hasil yang relevan walaupun pada beberapa poin memerlukan revisi.

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ABSTRAKPharmacists in the pharmaceutical industry has a professional responsibility to ensure that the quality of medicines produced meets the requirements and intended use by referring to the principles of Good Manufacturing Practice (GMP).Professional Pharmacist Internship is intended to provide practical experience and a real description of the role,duties and responsibilities of the pharmacist profession in the pharmaceutical industry.The internship was conducted at PT. AstraZeneca Indonesia for two months at quality assurance unit with the main activities were material induction from various departments,accomplising Annual Product Review (APR),accomplising Corrective Action Preventive Action (CAPA) and evidence based on self-inspection and accomplising procedures gap analysis.The induction which was given is about description of the tasks and functions of each departemen.The APR were two packing product APR of product I MY, I TW and I AU and also one repacking product APR of Z and B.As a result, both of packing and repacking products were released.Application of CAPA and evidence based on self-inspection documentation error were done by giving the SOP to the department who have unlisted previously.Wherease gap analysis of guidline the Robustness analysis and Process Trending with SOP Product Review Report and Standart Change Control in the Quality and also Compliance Operations Area and SOP Change Management with Change Management SOP still deliver a relevant results even if at some point require revision."

"Praktik Kerja Profesi Apoteker di Kimia Farma Trading & Distribution Bekasi untuk memahami tugas dan peran Apoteker di instansi Pedagang Besar Farmasi. Tugas khusus yang diberikan berjudul “Evaluasi Penanganan Psikotropika dan Narkotika Berdasarkan Form Inspeksi Diri di PT Kimia Farma Trading & Distribution Bekasi Periode 3-14 Oktober 2022”, dimana tugas ini bertujuan untuk mengetahui penanganan Psikotropika dan Narkotika di instansi PBF berdasarkan CDOB. Kegiatan evaluasi Penanganan Narkotika dan Psikotropika di KFTD Cabang Bekasi yang meliputi kegiatan Pengadaan, Penyimpanan, Penyaluran, serta Dokumentasi berdasarkan form inspeksi diri.

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Pharmacist Professional Work Practice at Kimia Farma Trading & Distribution Bekasi to understand the duties and roles of Pharmacists in Pharmaceutical Wholesalers agencies. The special assignment given is entitled "Evaluation of Psychotropics and Narcotics Handling Based on the Self-Inspection Form at PT Kimia Farma Trading & Distribution Bekasi for the period 3-14 October 2022", where this task aims to find out the handling of Psychotropics and Narcotics at PBF agencies based on CDOB. Evaluation activities for Narcotics and Psychotropics Handling at KFTD Bekasi Branch which include Procurement, Storage, Distribution, and Documentation activities based on self-inspection forms."

"Apotek merupakan sarana pelayanan kefarmasian tempat dilakukannya praktik kefarmasian oleh Apoteker (Kementerian Kesehatan Republik Indonesia, 2016). WHO menentukan sebuah standar bagi apoteker untuk dapat meningkatkan, menunjang akses, dan mendukung pelayanan di apotek yaitu Good Pharmacy Practice (GPP). PT. Kimia Farma Apotek melaksanakan penerapan GPP melalui penyediaan dan penerapan Standar Operating Procedure (SOP) yang di dalamnya telah diatur standar pelayanan kefarmasian yang perlu diterapkan oleh setiap apotek jaringan. Oleh karena itu dilakukan penilaian terhadap penerapan GPP di apotek Kimia Farma Menteng Huis berdasarkan SOP yang telah tersedia. Pelaksanaan tugas khusus Self-assesment GPP dilaksanakan berdasarkan formulir penilaian yang memuat sembilan kategori penilaian, yaitu legalitas apotek, penampilan apotek dan petugas, layanan obat dengan resep, layanan obat tanpa resep, SOP protokol new normal, morning briefing dan serah terima shift, delivery, homecare, telefarma, dan PRB community, penyimpanan obat. Penilaian dilakukan dengan pemberian poin 1 (Aspek tidak terlaksana), 2 (Aspek terlaksana Sebagian), atau 3 (aspek terlaksana sepenuhnya). Dari 9 kategori tersebur terdapat 50 aspek penilaian, sebanyak 30 aspek memperoleh poin 3, sebanyak 13 aspek memperoleh poin 2, dan sebanyak 7 aspek memperoleh poin 1.

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A pharmacy store is where the pharmacy practices were performed by the pharmacist. WHO had determined a standard for pharmacists to improve and support pharmacy practices and services in stores, which was Good Pharmacy Practice (GPP). PT. Kimia Farma Apotek implemented GPP through the provision and application of Standard Operating Procedures (SOP), which regulate the standards of pharmaceutical service and must be implemented by each Kimia Farma store. Therefore, an assessment of the implementation of GPP was carried out at the Kimia Farma Menteng Huis based on the available SOP. Implementation of this self-assessment was carried out based on an assessment form that contains nine assessment categories, namely pharmacy legality, pharmacy and staff appearance, prescription drug services, non-prescription drug services, new normal protocol SOP, morning briefing and shift handover, delivery, homecare, tele pharma, and PRB community, and medicines storage. The assessment is carried out by rate 1 point if the aspect was not implemented, 2 point if the aspect ix Universitas Indonesia was implemented partially, or 3 points if the aspect was fully implemented. From all the 9 categories there are 50 assessment aspects, Kimia Farma Menteng Huis got 30 aspects with 3 points, 13 aspects with 2 points, and 7 aspects with 1 point."