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"Pedagang Besar Farmasi (PBF) adalah perusahaan berbentuk badan hukum yang memiliki izin untuk pengadaa, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar sesuai ketentuann dalam peraturan perundang-undangan. Walaupun PBF telah beroperasi sesuai persyaratan CDOB, BPOM tetap merekomendasikan untuk dilakukan audit internal maupun eksternal dengan pemeriksaan langsung terhadap sarana distribusi untuk mengetahui pemenuhan persyaratan CDOB. Audit umumnya dilakukan minimal satu kali dalam satu tahun. Kemudian, dari temuan hasil audit akan dilakukan pembuatan Corrective Action Preventive Action (CAPA). Alur pembuatan CAPA berdasarkan SOP Pembuatan CAPA di KFTD Pusat, meliputi melakukan investigasi terkait kesesuaian audit/inspeksi; Apoteker Penanggung jawab membuat CAPA dengan menganalisis akar penyebab masalah dan tindakan perbaikan dan pencegahan; hasil CAPA didokumentasikan, diimplementasikan, dan diserahkan ke QA untuk evaluasi. Temuan atas audit/inspeksi oleh salah satu Prinsipal terhadap KFTD Pusat disesuaikan dengan persyaratan berdasarkan Peraturan BPOM Nomor 6 Tahun 2020 Tentang Pedoman Teknis Cara Distribusi Obat yang Baik atau peraturan perundang-undangan lain yang relevan. Pelaksanaan simulasi pembuatan CAPA atas temuan audit/inspeksi di KFTD Pusat telah disesuaikan dengan SOP Pembuatan CAPA KFTD Pusat dan Peraturan BPOM...... Pharmaceutical Wholesalers (PBF) 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. Even though PBF has operated in accordance with CDOB requirements, BPOM still recommends carrying out internal and external audits with direct inspection of distribution facilities to determine compliance with CDOB requirements. Audits are generally carried out at least once a year. Then, from the findings of the audit results, Corrective Action Preventive Action (CAPA) will be created. The flow of making a CAPA is based on the SOP for making a CAPA at the Central KFTD, including carrying out an investigation regarding the suitability of the audit/inspection; The Responsible Pharmacist creates a CAPA by analyzing the root causes of problems and corrective and preventive actions; CAPA results are documented, implemented, and submitted to QA for evaluation. The findings of the audit/inspection by one of the Principals of the Central KFTD are adjusted to the requirements based on BPOM Regulation Number 6 of 2020 concerning Technical Guidelines for Good Medicine Distribution Methods or other relevant laws and regulations. The implementation of the CAPA creation simulation based on audit/inspection findings at the Central KFTD has been adjusted to the SOP for Central KFTD CAPA Making and BPOM Regulations."

"Setiap pendirian PBF memerlukan Sertifikat Distribusi Farmasi sebagai bentuk persetujuan untuk melakukan pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar. Sertifikat distribusi yang dimaksudkan adalah Sertifikat Cara Distribusi Obat yang Baik (CDOB). CDOB merupakan suatu pedoman yang menetapkan cara distribusi atau penyaluran obat dan/atau bahan obat yang bertujuan untuk memastikan mutu sepanjang jalur distribusi/penyaluran sesuai persyaratan dan tujuan penggunaannya (Kementerian Kesehatan Republik Indonesia, 2018). Pada laporan ini akan dibahas lebih mendalam mengenai bab 5 dari CDOB, yakni terkait inspeksi diri. Inspeksi diri harus dilakukan dalam rangka memantau pelaksanaan dan kepatuhan terhadap pemenuhan CDOB. Apabila selama proses pengamatan dalam inspeksi diri ditemukan adanya penyimpangan dan/atau kekurangan, maka penyebabnya harus diidentifikasi dan dibuat CAPA. Sebagai bentuk pemenuhan CDOB, PBF KFTD Tangerang pun telah melakukan inspeksi diri melalui audit eksternal yang dilakukan oleh salah satu principal. Pada hasil audit tersebut ditemukan beberapa hal yang tidak sesuai dengan SOP yang telah ditetapkan oleh PBF KFTD Pusat. Oleh karena itu, penulis ditugaskan untuk Menyusun CAPA sebagai bentuk tindak lanjut dari hasil audit eksternal tersebut. Seluruh CAPA dan bukti pendukung yang disusun, didokumentasikan dan dilampirkan ke dalam laporan ini sehingga dapat memberikan gambaran dan contoh yang jelas terkait penyusunan CAPA yang benar (ISO/IEC 17025:2005).

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Every establishment of a distribution company requires a Pharmacy Distribution Certificate as a form of approval to procure, store, distribute drugs and/or drug ingredients in large quantities. The distribution certificate referred to is the Certificate of Good Distribution Practice (GDP). GDP is a guideline that stipulates the method of distribution or distribution of drugs and/or drug ingredients with the aim of ensuring quality along the distribution/distribution channels according to the requirements and purposes of their use (Ministry of Health of the Republic of Indonesia, 2018). This report will discuss in more detail chapter 5 of the GDP, which is related to self-inspection. Self-inspection should be carried out in order to monitor implementation and compliance with GDP compliance. If during the observation process during self-inspection, deviations and/or deficiencies are found, the cause must be identified and a CAPA made. As a form of compliance with GDP, PBF KFTD Tangerang has also conducted a self-inspection through an external audit conducted by one of the principals. In the audit results, several things were found that were not in accordance with the SOPs set by the Central KFTD PBF. Therefore, the author was assigned to prepare a CAPA as a form of follow-up to the results of the external audit. All CAPAs and supporting evidence are compiled, documented and attached to this report so as to provide a clear picture and example regarding the correct preparation of CAPAs (ISO/IEC 17025:2005)."

"Kegiatan produksi sebaiknya dilaksanakan menurut prosedur yang telah ditetapkan dan memenuhi ketentuan dari proses CPOB yang menjamin obat yang dihasilkan memenuhi persyaratan mutu serta memenuhi ketentuan izin pembuatan dan izin edar. Proses produksi dipengaruhi oleh kapasitas dari mesin maupun waktu total produksi.Kapasitas yang besar merupakan tujuan utama produksi untuk mendapatkan output sebanyak-banyakanya dalam waktu yang singkat. Peningkatkan kapasitas dapat dilakukan dalam berbagai proses produksi. Kapasitas ini mempengaruhi Production Cycle Time yaitu, waktu yang dibutuhkan satu batch produk dari datangnya bahan sampai rilis produk. CAPA merupakan bagian yang penting dalam penindaklanjutan inspeksi diri maupun deviasi. CAPA adalah proses yang membantu peningkatan dalam proses pada perusahaan. Hal ini penting untung terus mengembangkan perusahaan dalam banyak bagian. CAPA ini dapat terjadi karena deviasi maupun inspeksi diri. Inspeksi diri adalah untuk mengevaluasi apakah semua aspek produksi dan pengawasan mutu industri farmasi memenuhi ketentuan CPOB. Penambahan kapasitas pada proses produksi pada PT. Dankos Farma PKPA Periode 10 Januari-5 Maret 2021 dilaksanakan dengan melakukan pembuatan TSK sebagai standarisasi proses SUCU ganti produk pada mesin cetak tablet yang merupakan bottleneck proses produksi tablet secara keseluruhan, selain itu juga melakukan pembuatan TSK sebagai standarisasi proses coating yang merupakan bottleneck dari proses produksi tablet T yang sedang dibutuhkan serta pembuatan rekap data suhu dan RH untuk ruang Aging sebagai proses optimalisasi suhu dan RH yang mempercepat proses. Sementara itu, mengenai penyelesaian CAPA, 13 CAPA telah terimplementasi dan bukti telah di-submit untuk verifikasi dan 17 CAPA dalam tahap on progress karena membutuhkan data pendukung tambahan yang belum dapat diperoleh selama masa PKPA.

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Production activities should be carried out according to established procedures and comply with the provisions of the GMP process which ensures that the drug produced meets quality requirements and fulfills the provisions of the manufacturing permit and distribution permit. The production process is influenced by the capacity of the machine and the total time of production. Large capacity is the main goal of production to get as much output as possible in a short time. Increase capacity can be done in various production processes. This capacity affects Production Cycle Time i.e., the time it takes one batch of product from the arrival of the material to the release of the product. CAPA is an important part in the follow-up of self-inspection and deviation. CAPA is a process that helps improve processes in a company. This is important in order to continue to develop the company in many ways. This CAPA can occur due to deviation or self-inspection. Self-inspection is to evaluate whether all aspects of production and quality control of the pharmaceutical industry meet the GMP requirements. Increase capacity in the production process at PT. Dankos Farma PKPA 10 January - 5 March 2021 period was carried out by making TSK as a standardization of the SUCU process for changing products on tablet printing machines which is the bottleneck of the tablet production process as a whole, in addition to making TSK as a standardization of the coating process which is a bottleneck of the production process T tablets that are currently in need also making a recap of temperature and RH data for the Aging room as a temperature and RH optimization process that speeds up the process. Meanwhile, regarding the completion of the CAPA, 13 CAPAs have been implemented and evidence has been submitted for verification and 17 CAPAs are in the on progress stage because they require additional supporting data that cannot be obtained during the PKPA period."

"Berdasarkan PMK No. 34 Tahun 2014, Pedagang Besar Farmasi (PBF) dapat melakukan pengadaan perbekalan farmasi dalam jumlah besar yang langsung dari industri farmasi atau sesama PBF, sedangkan PBF Cabang hanya dapat melakukan pengadaan dari PBF pusat atau PBF Cabang lain atas rujukan PBF pusat dan pengadaan diatas namakan PBF pusat. Alur proses pengadaan pada PBF dan PBF Cabang harus menerapkan Standard Operational Procedure (SOP) serta sesuai dengan Prosedur Operasional Baku (POB) pada Cara Distribusi Obat yang Baik (CDOB). Seluruh rangkaian proses pada KFTD di Indonesia terintegrasi dalam satu sistem, yaitu System Analysis Program (SAP) sehingga memudahkan KFTD melakukan proses pengadaan, penyimpanan, dan penyaluran produk perbekalan farmasi. SAP menyediakan proses manajemen data yang terpusat dari pembelian bahan mentah, proses produksi, membuat perkiraan data, hingga kepuasan pelanggan terhadap produk perusahaan dalam satu sistem berbasis Enterprise Resource Planning (ERP). Dari hasil pengamatan dan analisis terhadap prosedur pengadaan produk non-Grup Kimia Farma di PT Kimia Farma Trading and Distribution Pusat (KFTD Pusat) didapatkan bahwa alur prosedur pengadaan produk non-Grup KF di KFTD Pusat secara umum telah sesuai dengan SOP pengadaan PT. Kimia Farma Tbk., namun prosedur tersebut perlu diperbaharui agar dapat mencakup seluruh alur prosedur pengadaan; simulasi pembuatan surat pesanan produk non-Grup KF berupa pengubahan surat Stock Transfer Order (STO) KFTD Cabang menjadi surat Purchase Order (PO) dilakukan secara terintegrasi dalam sistem System Analysis Program (SAP); dan Hambatan yang dialami oleh divisi Purchasing dalam pengadaan produk non-Grup KF adalah kesalahan pemasukan data harga produk dan bentuk kemasan produk pada surat pemesanan ke prinsipal.

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According to Ministerial Regulation No. 34 of 2014, Pharmaceutical Wholesalers (PBF) are authorized to procure pharmaceutical supplies in large quantities directly from pharmaceutical manufacturers or fellow PBFs. Branch PBFs, on the other hand, can only acquire supplies from the central PBF or other Branch PBFs under the central PBF's referral, acting on behalf of the central PBF. The procurement processes for both PBFs and Branch PBFs must adhere to Standard Operating Procedures (SOP) and align with the Standard Operational Procedures (POB) for Good Distribution Practices (CDOB). The entire supply chain process in Indonesia's pharmaceutical industry is streamlined through an integrated system known as the System Analysis Program (SAP). This integration simplifies procurement, storage, and distribution of pharmaceutical supplies. SAP provides centralized data management, spanning from the purchase of raw materials and production processes to data forecasting and customer satisfaction, all within an Enterprise Resource Planning (ERP) based system. Upon observation and analysis of the procurement procedures for non-Group Kimia Farma products at PT Kimia Farma Trading and Distribution Center (KFTD Center), it was found that the overall procurement process aligns with PT. Kimia Farma Tbk.'s procurement SOP. However, these procedures require updating to encompass the entire procurement process, integrate the transformation of Stock Transfer Orders (STO) from KFTD Branches into Purchase Orders (PO) seamlessly within the System Analysis Program (SAP). The Purchasing division faces challenges related to input errors in product prices and packaging formats in purchase orders to principals during the procurement of non-Group Kimia Farma products."

"Narkotika, psikotropika, prekursor, dan obat-obat tertentu merupakan obat atau bahan yang bermanfaat di bidang pengobatan atau pelayanan kesehatan dan pengembangan ilmu pengetahuan, namun penggunaannya sering kali disalahgunakan sehingga perlu diawasi dengan ketat terutama pada peredarannya. Penulisan tugas khusus ini bertujuan untuk membandingkan prosedur pengadaan, penerimaan, penyimpanan, dan penyaluran narkotika, psikotropika, prekursor, serta obat-obat tertentu di Kimia Farma Trading and Distribution cabang Jakarta 3 dengan pedoman SOP KFTD. Metode yang digunakan berupa penelusuran literatur dari berbagai website, peraturan perundang-undangan yang berlaku, dan wawancara dengan beberapa staf yang bekerja di KFTD kantor cabang Jakarta 3. Hasil dari kegiatan ini kemudian dibandingkan dengan SOP KFTD. Berdasarkan penelusuran yang dilakukan, dapat disimpulkan bahwa proses pengadaan, penerimaan, penyimpanan, penyaluran narkotika, psikotropika, prekursor, dan obat-obat tertentu sudah sesuai dengan ketentuan SOP KFTD.

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Narcotics, psychotropic, precursors, and certain medicines are drugs or materials that are useful in the field of medical treatment or health services and the development of science, but their use is often misused so it needs to be closely monitored, especially in its circulation. The writing of this special task aims to compare the procedures for procurement, reception, storage, and distribution of narcotics, psychotropic, precursors, and certain medicines at the Kimia Farma Trading and Distribution of the Jakarta Branch 3 with KFTD SPO Guidelines. The method used in this special work practice is gaining literature from various websites, applicable laws and regulations, and interviews with several staff working at the Jakarta Branch Office KFTD 3. The results of this activity are then compared to the KFTD SPO. Based on the search conducted, it can be concluded that the process of procurement, reception, storage, distribution of narcotics, psychotropic, precursors, and certain medicines is in accordance with the provisions of the KFTD SPO."

"[ABSTRAK Praktek Kerja Profesi PKP dilakukan di PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat dan KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur Kegiatan PKP ini bertujuan agar mampu memahami peranan tugas dan tanggung jawab Apoteker di Pedagang Besar Farmasi memiliki wawasan pengetahuan keterampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Pedagang Besar Farmasi memahami penerapan Cara Distribusi Obat yang Baik CDOB di Pedagang Besar Farmasi serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Pedagang Besar Farmasi Pada pelaksanaan Praktek Kerja Profesi dilakukan pembuatan tugas khusus oleh mahasiswa calon Apoteker yang memiliki judul rancangan penempatan perbekalan farmasi kuantitas besar dan alat kesehatan di gudang KFTD Cabang Jakarta 2 Tugas khusus ini bertujuan untuk mempermudah pencarian produk dan memanfaatkan seluruh ruang di gudang KFTD Cabang Jakarta 2 secara optimal ABSTRACT The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally ;The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally ;The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally ;The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally ;The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally , The profession internship was implemented at PT Kimia Farma Trading Distribution KFTD Jalan Budi Utomo No 1 Jakarta Pusat and KFTD Cabang Jakarta 2 Jl Pulo Kambing Kav J No 15 Jakarta Timur It was aimed to understand roles duties and responsibilities of a pharmacist in pharmaceutical distributor to get insights knowledges skills and experiences about how to do pharmaceutical work in pharmaceutical distributor to understand the implementation of Cara Pembuatan Obat yang Baik CDOB in Pharmaceutical Distributor and to get the real picture about troubles in Pharmaceutical Distributor When implementing the profession internship carried out the special task of designing the placement of large quantity pharmaceutical supplies and medical devices in the warehouse of KFTD Cabang Jakarta 2 That special task was aimed to ease product finding and to utilize the whole room in the warehouse of KFTD Cabang Jakarta 2 optimally ]"