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"Industri Farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat dan bahan obat. Pemerintah Indonesia melalui Keputusan Menteri Kesehatan No.43/Menkes/SK/II/1988 tentang Cara Pembuatan Obat yang Baik (CPOB) berusaha menjamin mutu obat yang dihasilkan industri farmasi meliputi serangkaian kegiatan produksi hingga obat jadi yang dihasilkan memenuhi syarat dan sesuai dengan tujuan penggunaannya. Penerapan pedoman CPOB ini diharapkan dapat meningkatkan mutu produk obat secara terus menerus dan memberikan perlindungan terhadap kesehatan masyarakat serta menjadi langkah progresif bagi perkembangan industri farmasi di Indonesia sehingga mendapat pengakuan dan kepercayaan dari konsumen. Oleh karena itu, apoteker harus memiliki kompetensi yang baik dalam menjamin pelaksanaan CPOB berjalan sesuai persyaratan. Praktek Kerja Profesi Apoteker (PKPA) yang dilakukan pada 9 September - 31 Oktober 2013 di PT. Taisho Pharmaceutical Indonesia Tbk. dalam rangka memperoleh pengetahuan dan wawasan mengenai penerapan aspek-aspek CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. serta memahami peran dan tugas apoteker dalam industri farmasi.

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Pharmaceutical Industry is an entity that has the permission of the Minister of Health to conduct the manufacture of drugs and drug ingredients. Indonesian Government through the Minister of Health No.43/Menkes/SK/II/1988 on Good Manufacturing Practice (GMP) seeks to ensure the quality of drug produced by the pharmaceutical industry includes the production of a series of events to be generated drug and qualified in accordance with the intended use. The application of GMP guidelines is expected to improve the quality of drug products continuously and provide protection to public health as well as being a progressive step for the development of the pharmaceutical industry in Indonesia, so it gets the recognition and trust of consumers. Therefore, pharmacists must have a good competence in ensuring the implementation goes according to GMP requirements. Pharmacist Internship Program (PKPA) conducted on September 9th to October 31th 2013 in the PT. Taisho Pharmaceutical Indonesia Tbk. in order to gain knowledge and insight about the implementation aspects of GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and understand the role and duties of the pharmacist in the pharmaceutical industry."

"Industri farmasi merupakan salah satu komponen penting yang bertanggung jawab terhadap mutu, khasiat, dan keamanan obat yang dikonsumsi oleh masyarakat. Cara Pembuatan Obat Yang Baik (CPOB) adalah pedoman kerja bagi industri farmasi di Indonesia untuk menyediakan obat yang berkualitas. Untuk mendukung persyaratan mutu yang ditetapkan tidak luput dari peran personil yang berperan di industri farmasi. Salah satu dari personil tersebut adalah apoteker. Peraturan Pemeritah nomor 51 tahun 2009 tentang Pekerjaan Kefarmasian menyebutkan bahwa setiap industri farmasi wajib mempunyai minimal tiga orang Apoteker berkewarganegaraan Indonesia yang menempati bagian produksi, pemastian mutu, dan pengawasan mutu. Oleh sebab itu, Fakultas Farmasi Universitas Indonesia bekerjasama dengan PT Taisho Pharmaceutical Indonesia Tbk untuk menyelenggarakan program Praktik Kerja Profesi Apoteker pada 9 September - 30 Oktober 2013. Tugas Khusus dengan judul "Titik Kritis Pada Proses Penimbangan, Pengolahan, Pengisian Hingga Pengemasan Produk Tempra®" bertujuan untuk mengetahui titik kritis pada proses produksi yang dapat mempengaruhi kualitas produk.

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The Pharmaceutical Industry is one of the main parts which are responsible for the quality, efficacy, and safety of drugs consumed by the public. Good Manufacturing Practice (GMP) is a working guideline for the pharmaceutical industry in Indonesia to provide quality drugs. To support the quality requirements, it's on the hand of the personnel who played a role in the pharmaceutical industry. One of these personnel is a pharmacist. Government Regulation no.51st in 2009 on Pharmaceutical Works mention that every pharmaceutical industries required to have a minimum of three Indonesian nationals Pharmacists who have full obligation in production, quality assurance, and quality control. Therefore, Faculty of Pharmacy, University of Indonesia coorporating with PT Taisho Pharmaceutical Indonesia Tbk toorganized Pharmaceutical Internship Program in 9 September - 30 October 2013. Specific Assignment titled "Critical Point in Dispensing, Mixing, Filling and Packaging Process of Tempra® Product" aims to determine critical points in production process that can affect the quality of the product."

"Pharmaceutical Industry is the place to meet the needs of public health by increasing the quantity and quality of the drug to be in production All drugs are in production and will be circulated to be guaranteed safety efficacy and quality To achieve this we need a guideline that covers all aspects of production and quality control in order to ensure the drug is made consistently meeting the requirements set out and in accordance with their intended use namely the Good Manufacturing Practice GMP All GMP pharmaceutical industry shall apply in all aspects and activities of a series of drug manufacturing Work Practice Pharmacist PKPA conducted during the period 17 June to 30 August 2013 in the PT Taisho Pharmaceutical Indonesia Tbk to provide supplies for prospective pharmacists to apply the knowledge they have learned during the course in a practical and direct the quality control of drugs in the Pharmaceutical Industry The PKPA activities aimed to compare the application of the provisions of the implementation of GMP in Pharmaceutical Industry particularly in PT Taisho Pharmaceutical Indonesia Tbk dan understand the duties and responsibilities of pharmacists in the Pharmaceutical Industry is mainly in charge of production quality assurance and quality control "

"Praktek kerja profesi apoteker di PT Taisho Pharmaceutical Indonesia Tbk dilakukan agar calon apoteker mendapatkan bekal pengetahuan dan pengalaman yang memadai untuk melakukan pekerjaan kefarmasian serta aplikasi prinsip CPOB di Industri farmasi Tugas khusus yang dikerjakan berjudul Evaluasi Prosedur Tetap Penyiapan dan Penanganan Logbook di PT Taisho Pharmaceutical Indonesia Tbk Evaluasi dilakukan untuk menghilangkan sesuatu yang tidak diperlukan yang bersifat ganda serta melengkapi kelengkapan data yang penting untuk dijadikan focus utama Hasil dari evaluasi yang dilakukan adalah benrtuk standar format logbook dan prosedur tetapnya yang diaplikasikan di senua departemen di PT Taisho Pharmaceutical Indonesia Tbk

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Pharmacists Professional Practice at PT. Taisho Pharmaceutical Indonesia Tbk., aims to make the pharmacist candidate got enough experience and education to do the pharmaceutical jobs and also the application of GMP in pharmaceutical industry. The special assignment was evaluation of standard operational and procedure about preparation and management of logbook at PT. Taisho Pharmaceutical Indonesia Tbk., The evaluation aims to eliminate the unwanted things that doubled and also to complete the data needed that use as the main focus. The result of this evaluation is standardize logbook and the standard operation and procedure that applicable in all department in PT. Taisho Pharmaceutical Indonesia Tbk."

"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho Pharmaceutical Indonesia Tbk., bertujuan agar mahasiswa profesi apoteker dapat meningkatkan pengetahuan dan wawasan mengenai CPOB dalam segala aspek pada industri farmasi terutama penerapan CPOB di PT. Taisho Pharmaceutical Indonesia Tbk., serta mengetahui dan memahami peran dan tanggung jawab Apoteker dalam industri farmasi yang diharapkan dapat menjadi bekal untuk menghadapi dunia kerja yang sesungguhnya. Tugas khusus yang diberikan berjudul Simplifikasi Dokumen Manufacturing Instruction (MI), Packaging Instruction (PI), dan Laboratory Report. Tugas khusus ini bertujuan untuk menyederhanakan ketiga dokumen tersebut sehingga menghindari pengisian dokumen dengan informasi yang sama secara berulang-ulang.

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Pharmacist internship at PT. Taisho Pharmaceutical Indonesia Tbk., aims to improve pharmacist student’s knowledge and insight regarding all aspects of GMP in the pharmaceutical industry, especially the implementation of GMP in PT. Taisho Pharmaceutical Indonesia Tbk., and to know and understand the roles and responsibilities of pharmacists in the pharmaceutical industry. It is expected to help pharmacist student to face the real working world. The special task is about simplification of Manufacturing Instruction (MI), Packaging Instruction (PI), and the Laboratory Report. This special task aims to simplify the those documents thus avoiding the charging document with the same information repeatedly."

"Apoteker merupakan salah satu tenaga inti dalam industri farmasi yang turut berperan dalam menghasilkan obat yang bermutu, aman, dan berkhasiat. Kedudukan Apoteker juga diatur dalam CPOB, yaitu sebagai penanggung jawab produksi, pengawasan mutu dan pemastian mutu sehingga seorang Apoteker dituntut untuk mempunyai wawasan, pengetahuan, keterampilan, dan kemampuan dalam mengaplikasikan dan mengembangkan ilmunya secara profesional agar dapat mengatasi permasalahan-permasalahan yang ada di industri farmasi. Dalam rangka mencapai tujuan tersebut, calon Apoteker perlu mendapatkan bekalpengetahuan dan pengalaman yang memadai yang salah satu caranya dapat diperoleh melalui kegiatan praktek kerja profesi di industri farmasi. PKPA dilaksanakan di PT. Taisho Pharmaceutical Indonesia Tbk. Pelaksanaan praktek kerja berlangsung dari tanggal 01 Juli – 29 Agustus 2014.

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Pharmacists are one of the core force in the pharmaceutical industry that played a role in generating drug quality, safe, and efficacy. Position Pharmacists are also set in the GMP, which is in charge of production, quality control and quality assurance so that a pharmacist is required to have the insight, knowledge, skills, and ability to apply and develop their knowledge in a professional manner in order to overcome the problems that exist in the pharmaceutical industry. In order to achieve these objectives, prospective pharmacists need to gain knowledge and experience sufficient that one of the ways can be obtained through the practice of the profession work in the pharmaceutical industry. PKPA conducted in PT. Taisho Pharmaceutical Indonesia Tbk. Implementation of the internship runs from July 1 to August 29, 2014."

"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho Pharmaceutical Indonesia Tbk. Jalan Raya Bogor KM. 38. Kegiatan PKPA ini bertujuan agar mahasiswa profesi apoteker dapat meningkatkan pengetahuan dan wawasan tentang segala aspek industri farmasi yang berhubungan dengan CPOB serta mengetahui penerapan CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. Selain itu, mahasiswa profesi apoteker diharapkan mengetahui dan memahami peran dan tanggung jawab Apoteker dalam industri farmasi khususnya di PT. Taisho Pharmaceutical Indonesia Tbk. sehingga dapat menjadi bekal untuk menghadapi dunia kerja yang sesungguhnya. Tugas khusus yang diberikan berjudul Simplifikasi Alur Laboratory Report. Tugas khusus ini bertujuan untuk melakukan simplifikasi alur proses Laboratory Report di Departemen Pengawasan Mutu (Quality Control) dengan tetap memenuhi prinsip CPOB.

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Pharmacist Internship Program is held in PT. Taisho Pharmaceutical Indonesia Tbk. Jalan Raya Bogor KM. 38. The objective of this internship is to increase knowledge and perspective about every aspect in pharmaceutical industry related to GMP and its implementation in PT. Taisho Pharmaceutical Indonesia Tbk. In addition, profession pharmacist is expected to know and understand their role and responsibility in pharmaceutical industry particularly in PT. Taisho Pharmaceutical Indonesia Tbk., hence will be able to face the job in the real world. The title of the specific assignment is Flow Process Simplification of Laboratory Report. The aim of this specific assignment is to simplify the flow process of Laboratory Report in Quality Control Department in accordance with GMP."

"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho Pharmaceutical Indonesia – Jalan Raya Bogor Km 38 Bogor. Kegiatan PKPA ini bertujuan untuk meningkatkan pengetahuan dan wawasan tentang segala aspek yang terkait di industri farmasi terutama dalam hal penerapan CPOB di PT. Taisho Pharmaceutical Indonesia Tbk. dan dapat memiliki pemahaman mengenai tanggung jawab apoteker di industri farmasi. Tugas khusus yang diberikan berjudul Simplifikasi Alur dan Dokumen Manufacturing Instruction (MI) dan Packaging Instruction (PI). Tugas khusus ini bertujuan untuk mempermudah pekerjaan yang dilakukan oleh personil yang bekerja seperti memberikan kemudahan pengisian dokumen, serta menghilangkan proses yang tidak perlu dan secara tidak langsung dapat menurunkan biaya produksi yang pada akhirnya dapat meningkatkan nilai produk.

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Pharmacist Internship Program at PT. Taisho Pharmaceutical Indonesia – Jalan Raya Bogor Km 38 Bogor was intended to acquire knowledge and insight about every aspect in pharmaceutical industry which particularly focus on GMP implementation in PT. Taisho Pharmaceutical Indonesia Tbk as well as the responsibilities of Pharmacist in pharmaceutical industry. The special task given was titled Simplification of Flow and Document of Manufacturing Instruction (MI) and Packaging Instruction (PI). This assignment was aimed to simplify the work performed by personnel working as provide ease of filling documents, as well as eliminating unnecessary processes and can indirectly reduce the cost of production, which in turn can increase the value of the product."

"ABSTRAKPraktek Kerja Profesi Apoteker dilaksanakan di PT. Taisho PharmaceuticalIndonesia Tbk. Jalan Raya bogor KM 38. Kegiatan PKPA ini bertujuan agarmahasiswa profesi apoteker dapat melihat langsung aktivitas yang berlangsungdalam suatu industri farmasi, memperoleh pengetahuan dan wawasan tentangsegala aspek yang terkait di industri farmasi terutama dalam hal penerapan CPOBdi PT. Taisho Pharmaceutical Indonesia dan dapat memiliki pemahaman yangmendalam mengenai peran dan tugas apoteker di industri farmasi. Tugas khususyang diberikan berjudul Pembuatan Format Annual Product Quality Review(APQR)

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ABSTRACTPharmacists Professional Practice implemented in PT. Taiho PharmaceuticalIndonesia Tbk., Jalan Raya Bogor KM38. PKPA activity is intended that studentscan see the direct profession pharmacists activity that takes place in thepharmaceutical industry, gaining knowledge and insight into everything relatedaspects in the pharmaceutical industry, especially in terms of the implementationof GMP in PT. Taisho Pharmaceutical Indonesia Tbk. and may have a deepunderstanding of the role and duties of the pharmacist in the pharmaceuticalindustry. Special task given New Format of Annucal Product Quality Review (APQR)."

"Praktik kerja profesi apoteker di PT. Taisho Pharmaceutical bertujuan untuk mengetahui peran apoteker dalam industri farmasi. Di Industri farmasi apoteker memegang peran penting dalam proses produksi, pengendalian mutu dan pemastian mutu dari produk farmasi yang dihasilkan. Di dalam proses produksi, salah satu peran apoteker adalah menjamin proses produksi dijalankan sesuai dengan kaidah Cara Pembuatan Obat yang Baik. Oleh karena itu, proses produksi selalu didokumentasikan dalam batch record yang terdiri dari dokumen pengelolaan induk dan dokumen pengemasan induk. Dokumen pengemasan induk berisi informasi terkait proses pengemasan tiap produk spesifik yang disusun secara jelas untuk menghasilkan produk akhir yang aman, bermutu dan berkhasiat serta ekonomis. Dalam mencapai tujuan tersebut, PT. Taisho Pharmaceutical melakukan simplifikasi dokumen pengemasan induk yang mengacu pada konsep lean manufacturing. Selama program praktik kerja ini, telah berhasil dilakukan simplifikasi dokumen pengemasan induk dari produk theragran tablet, engran tablet, kenacort tablet, myco-z cream, kenalog in oral base, stugeron tablet, Imodium tablet, daktarin cream 5 gram, daktarin cream 10 gram, dan nizoral ss 1%.

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Pharmacist internship in PT. Taisho Pharmaceutical aims to determine the role of pharmacists in the pharmaceutical industry. Pharmacist in pharmaceutical industry plays an important role in the production process, quality control and quality assurance of pharmaceutical products produced. In the production process, one of the pharmacist's role is to ensure that the production process is executed in accordance with the principles of Good Manufacturing Practice. Therefore, the production process is always documented in the batch record consisting of manufacturing instruction and packaging instruction. Packaging instruction contains information about packaging process for each specific product are clearly arranged to produce a final product that is safe, quality, efficacious and economical. In achieving these objectives, PT. Taisho Pharmaceutical did simplification for the packaging instruction with the concept of lean manufacturing. During internship, successfully did simplification of packaging instruction of theragran tablets, engran tablets, kenacort tablets, Myco-z cream, kenalog in oral base, stugeron tablets, Imodium tablets, daktarin cream 5 grams, 10 grams of daktarin cream, and Nizoral SS 1%."