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Rizki Fadhilah
"ABSTRAK
Pada Peraturan Pemerintah No. 51 tahun 2009, disebutkan bahwa pekerjaan
kefarmasian salah satunya dapat dilakukan di fasilitas produksi sediaan farmasi,
seperi industri farmasi obat. Dalam melakukan pekerjaan kefamasian di industri
farmasi, dibutuhkan sumber daya yang memiliki pemahaman mengenai Cara
Pembuatan Obat yang Baik (CPOB). Program Studi Apoteker Fakultas Farmasi
Universitas Indonesia menyelenggarakan Praktek Kerja Profesi Apoteker, salah
satunya di PT. AstraZeneca Indonesia, pada periode 4 Januari hingga 29 Februari
2016, yang bertujuan untuk mengerti peranan, tugas, dan tanggung jawab
apoteker, memiliki wawasan, pengetahuan, ketrampilan, dan pengalaman praktis
untuk melakukan pekerjaan kefarmasian, memahami penerapan CPOB, serta
memiliki gambaran nyata tentang permasalahan pekerjaan farmasi di industri
farmasi.

ABSTRACT
Refers to PP No. 51 in 2009, state that one of place to held pharmaceutical service
is in manufacturing pharmaceutical products, such as in Pharmaceutical Industry.
To held pharmaceutical service, it needs a comprehensive knowledge about Good
Manufacturing Practices (GMP). One of industry that internship from Apothecary
Program of Fakultas Farmasi UI was held at PT. AstraZeneca Indonesia, from 4
January to 29 February 2016, that was aimed to understand the roles, duty, and
responsibilities to held pharmaceutical services, understand the application of
Good Manufacturing Practices, and to know about the real problems of
pharmaceutical services in pharmaceutical industry.;"
2016
PR-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Hervinda Dita Kristianti
"ABSTRAK
Praktek Kerja Profesi Apoteker di PT Novell Pharmaceutical Laboratories dilaksanakan pada bulan Juli sampai September tahun 2016. Pelaksanaan praktek kerja profesi ini bertujuan untuk memahami peran serta tanggung jawab Apoteker di industri farmasi dan dalam proses pengembangan produk, khususnya di Departemen Business Development PT. Novell Pharmaceutical Laboratories. Proses pengembangan produk obat dan regulasi obat di industri farmasi harus sesuai dengan aturan pemerintah Indonesia. Tugas khusus diberikan berjudul penyusunan dokumen registrasi nonklinik dan klinik larutan injeksi magnesium sulfat sesuai kriteria dan tatalaksana registrasi obat oleh Badan Pengawas Obat dan Makanan BPOM . Tujuan penyusunan tugas khusus adalah untuk mengetahui tujuan dilakukan penyusunan dokumen klinik dan nonklinik serta memahami prosedur penyusunan dokumen klinik dan nonklinik injeksi magnesium sulfat sesuai dengan Kriteria dan Tatalaksana Registrasi Obat oleh BPOM.

ABSTRACT
Pharmacists profession internship at PT Novell Pharmaceutical Laboratories was held on July to September 2016. Implementation of this internship aimed to understand the role and responsibilities of pharmacists in the pharmaceutical industry and the development of medicinal products, especially in Department of Business Development, PT. Novell Pharmaceutical Laboratories. The process of development of medicinal products in the pharmaceutical industry must be in accordance with the rules of the Indonesian government. Special task given to support the internship activities was entitled Preparation of Non Clinical and Clinical Registration Documents of Magnesium Sulfate Injection according to the drug registration criteria and procedure by drug and food supervisory agency BPOM . The purpose of the special task are to understand the purpose of composing clinic and nonclinical documents, as well as understand the procedure of clinical and nonclinical documents arrangement of magnesium sulfate injection in accordance with BPOM drug registration criteria and procedure."
Depok: Fakultas Farmasi Universitas Indonesia, 2017
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Atvinda Prilya Afista
"ABSTRAK
Praktek Kerja Profesi (PKP) di industri farmasi dilaksanakan di Departemen
Quality Control (QC) PT Medifarma Laboratories. Kegiatan ini berlangsung
selama 2 bulan dari tanggal 1 Juli sampai dengan tanggal 31 Agustus 2015. PKP di
industri bertujuan agar mahasiswa apoteker mengerti peranan, tugas, dan tanggung
jawab Apoteker di Industri Farmasi; memiliki wawasan, pengetahuan,
keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di
Industri Farmasi; memahami penerapan CPOB di Industri Farmasi; memiliki
gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi.
Berdasarkan kegiatan PKP yang dilakukan, dapat disimpulkan bahwa peran
apoteker penting untuk menghasilkan obat-obatan yang aman, bermutu, dan
berkhasiat. Apoteker di Departemen QC bertanggung jawab untuk melakukan
pengawasan mutu terhadap produk yang diproduski dan memastikan bahwa
pengujian yang diperlukan dan relevan telah dilakukan dan bahwa bahan yang
belum diluluskan tidak digunakan serta produk yang belum diluluskan tidak dijual
atau dipasok sebelum mutunya dinilai dan dinyatakan memenuhi syarat. Mahasiswa
apoteker telah berhasil memperoleh gambaran umum dari pelaksanaan pekerjaan
kefarmasian di PT Medifarma., khususnya di bidang QC yaitu melakukan analisis
terhadap bahan awal, produk jadi, inspeksi bahan awal. Dalam melakukan tugasnya
di QC juga mahasiswa apoteker membuat Spreadsheet dan cara memvalidasinya
untuk mendukung analisis dan inspeksi bahan awal. Adanya PKP di PT Medifarma
Laboratories yang telah melaksanakan CPOB dengan baik di semua aspek, peserta
PKP lebih banyak mengetahui dan memahami seperti apa pelaksanaan CPOB
secara real dalam sebuah Industri. Seperti Industri yang lainnya PT Medifarma
Laboratories juga memiliki masalah seperti berpikir bagaimana mengatasi waste
time pada proses maupun para pekerja sehingga suatu proses berlangsung lebih
cepat tetapi tetap menghasilkan hasil yang baik dan dapat dipertanggungjawabkan,
Oleh karena itu, Apoteker harus memiliki wawasan, pengetahuan dan kreatifitas
sehingga dapat mengatasi masalah-masalah tersebut.

ABSTRACT
Profession Internship at pharmaceutical industry was held at Quality Control (QC)
Department of PT Medifarma Laboratories. This activity was held for two month
from July 1
st
until August 31
th
2015. Profession internship at pharmaceutical
industry was intended to make apothecary student understand the role of
pharmacist, have insight into the implementation of pharmaceutical practice,
understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), and
know the issues in pharmaceutical practice in pharmaceutical industry. Based on
the activities, Apothecary at QC Department is responsible for supervising the
quality of the product diproduski and ensure that the necessary and relevant tests
have been conducted and that the materials have not been approved are not used as
well as products that have not been approved are not sold or supplied before the
quality was assessed and found eligible. Apothecary student have obtained insight
into general routine activities in QC Department, those were an analysis of the
starting materials, finished products, inspection of the starting material. In
performing the task in QC department, apothecary student make a spreadsheet and
validate them to support the analysis and inspection of the starting material. PT
Medifarma Laboratories that has implemented the GMP well in all aspects, give
apothecary student more aware and understand what the real implementation of
GMP in an industry. Such as Industrial others, PT Medifarma Laboratories also has
a problem such as find solution how to solve waste time in the process or the
workers, so that a process was faster but still produce good results. Therefore,
pharmacists should have the insight, knowledge and creativity so that can overcome
the problems.
;Profession Internship at pharmaceutical industry was held at Quality Control (QC)
Department of PT Medifarma Laboratories. This activity was held for two month
from July 1
st
until August 31
th
2015. Profession internship at pharmaceutical
industry was intended to make apothecary student understand the role of
pharmacist, have insight into the implementation of pharmaceutical practice,
understand the implementation of Cara Pembuatan Obat yang Baik (CPOB), and
know the issues in pharmaceutical practice in pharmaceutical industry. Based on
the activities, Apothecary at QC Department is responsible for supervising the
quality of the product diproduski and ensure that the necessary and relevant tests
have been conducted and that the materials have not been approved are not used as
well as products that have not been approved are not sold or supplied before the
quality was assessed and found eligible. Apothecary student have obtained insight
into general routine activities in QC Department, those were an analysis of the
starting materials, finished products, inspection of the starting material. In
performing the task in QC department, apothecary student make a spreadsheet and
validate them to support the analysis and inspection of the starting material. PT
Medifarma Laboratories that has implemented the GMP well in all aspects, give
apothecary student more aware and understand what the real implementation of
GMP in an industry. Such as Industrial others, PT Medifarma Laboratories also has
a problem such as find solution how to solve waste time in the process or the
workers, so that a process was faster but still produce good results. Therefore,
pharmacists should have the insight, knowledge and creativity so that can overcome
the problems."
2016
PR-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Pasaribu, Anju Hasiholan Daniel
"Praktek Kerja Profesi Apoteker di PT. Ristra Indolab Jl. Lanbow, Kp. Lio Baru, Ds. Sanja, Kec. Citereup, Kab. Bogor, Jawa Barat bertujuan untuk menegtahui penerapan CPKB di PT. Ristra Indolab dan memahami tugas fungsi Apoteker di Industri kosmetik. Tugas khusus yang dilakukan adalah keamanan dan penggunaan paraben dalam sediaan makanan, kosmetik dan farmasi.
Tujuan dalam penulisan tugas khusus ini adalah mengetahui perkembangan informasi mengenai penggunaan, toksisitas dan efek samping paraben dengan melakukan studi pustaka terhadap literatur dan jurnal penelitian yang telah dipublikasikan.

Pharmacists Professional Practice in PT. Ristra Indolab Jl. Lanbow, Kp. Lio Baru, Ds. Sanja, Kec. Citereup, Kab. Bogor, Jawa Barat application aims to know GMP in PT. Ristra Indolab and understand the task function Pharmacists in cosmetic industry. The specific task performed is the security and the use of parabens in the preparation of food, cosmetics and pharmaceuticals.
The purpose in writing this particular task was to determine the development of information regarding the use, toxicity and side effects of parabens and conduct library research of the literature and research journals that have published.
"
Depok: Fakultas Farmasi Universitas Indonesia, 2013
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UI - Tugas Akhir  Universitas Indonesia Library
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Riza Apriani
"Praktek Kerja Profesi Apoteker di PT. Novell Pharmaceutical Laboratories bertujuan untuk mengetahui dan memahami peran dan tanggung jawab apoteker di industri farmasi serta di departemen Business Development PT Novell Pharmaceutical Laboratories. Tugas khusus yang diberikan berjudul perbedaan persyaratan kelengkapan dokumen registrasi obat jadi copy negara Malaysia dan Indonesia. Tugas khusus ini bertujuan agar mahasiswa mengetahui perbedaan persyaratan kelengkapan dokumen registrasi obat jadi copy antara Negara Malaysia dan Indonesia, sehingga mendapatkan informasi yang lengkap untuk menyiapkan dossier negara tersebut yang disusun sesuai dengan format Asean Common Technical Dossier (ACTD). ASEAN Common Technical Dossier (ACTD) adalah pedoman yang disepakati bersama sebagai format umum dalam penyusunan dossier teknis yang terstruktur dengan baik yang diserahkan kepada badan regulasi ASEAN yang berwenang untuk mendaftarkan produk farmasi yang digunakan manusia. Pedoman ini menjelaskan format CTD yang secara signifikan akan menghemat waktu dan sumber daya yang dibutuhkan untuk pengumpulan berkas pendaftaran. Metode yang digunakan adalah melalui penelusuran literatur (studi pustaka). Kelengkapan dokumen registrasi obat jadi copy di Negara Malaysia dan Indonesia memiliki banyak kesamaan, perbedaan nya terdapat pada bagian I dan bagian II. Persyaratan kelengkapan dokumen registrasi obat jadi copy antara Negara Malaysia dan Indonesia mengacu pada pedoman ACTD, hanya penyusunan dan titik berat evaluasi di sub bagian tertentu sedikit berbeda, sehingga kedua negara anggota ASEAN ini telah sepenuhnya mengadopsi Pedoman Harmonisasi ACTD.

Apothecary Internship Report at PT. Novell Pharmaceutical Laboratories aimed to know and learn duties and functions of apothecary in pharmacy industry and Business Development of PT Novell Pharmaceutical Laboratories. Special assignment title which is given is difference regulation of comprehensive copy drugs registration document between Malaysia dan Indonesia country. This special assignment aimed to know difference regulation of comprehensive copy drugs registration document between Malaysia dan Indonesia country, then getting complete information to prepare dossier of the country which is arranged with Asean Common Technical Dossier (ACTD) form. ASEAN Common Technical Dossier (ACTD) is guideline which is agreed as common form in arrangement of technical dossier with good structural which is given for ASEAN regulation agency to register pharmacy product to human. This guideline clarifying CTD form significantly less a time and resources which is needed to collect registration document. Method which is used is literature study. Comprehensive of copy drugs registration document in Malaysia dan Indonesia country have much similiarity, its difference is on Part I and part II. Regulation of comprehensive copy drugs registration document between Malaysia dan Indonesia country refer to ACTD guideline, just an arrangement and evaluation balance point in certain sub section is a little different, so both of this ASEAN member country have adopted ACTD guideline harmonization.
"
Depok: Fakultas Farmasi Universitas Indonesia, 2012
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UI - Tugas Akhir  Universitas Indonesia Library
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Lidwina Deviani Likasa
"Apoteker memegang peranan penting di industri farmasi, apotek, dan pemerintahan. Seorang apoteker harus memenuhi standar kompetensi sebagai persyaratan untuk memasuki dunia kerja dan menjalankan praktik profesi. Standar kompetensi apoteker Indonesia terdiri dari sepuluh standar kompentensi sebagai kemampuan yang diharapkan oleh apoteker saat lulus dan masuk ke tempat praktik kerja profesi. Sebagai bekal dan pengalaman calon apoteker untuk dapat memahami peran apoteker dan meningkatkan kompetensi, maka dilaksanakan Praktik Kerja Profesi Apoteker di PT. Novell Pharmaceutical Laboratories, Apotek Hidup Baru, dan Suku Dinas Kesehatan Kota Administrasi Jakarta Timur selama periode bulan Januari-April 2019. Selama PKPA, diharapkan calon apoteker dapat memperluas wawasan, pemahaman, dan pengalaman untuk melakukan pekerjaan kefarmasian di tempat praktik kerja profesi.

Pharmacists have an important role as one of the healthcare professional. Pharmacists must comply with the competency standards before get into the professional practices. Therefore, in order to get experiences working as a healthcare professional, the Pharmacists Internship Program that called as Praktik Kerja Profesi Apoteker (PKPA) have been implemented. The prospective pharmacists get to do the internship at several places, such as PT. Novell Pharmaceutical Laboratories, Apotek Hidup Baru, and East Jakarta Administration City Health Office period January-April 2019. The prospective pharmacists are expected to get more knowledge and experiences to do the pharmaceutical practices in various places during the PKPA. "
Depok: Fakultas Farmasi Universitas Indonesia, 2019
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UI - Tugas Akhir  Universitas Indonesia Library
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Dina Risma Wati
"ABSTRAK
Praktik kerja profesi di PT Novell Pharmaceutical Laboratories bertujuan untuk mengerti peran, tugas, dan tanggung jawab apoteker di industri farmasi, serta memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Calon apoteker juga dapat memahami penerapan Cara Pembuatan Obat yang Baik CPOB di industi farmasi dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Praktik kerja profesi dilakukan di Departemen Product Development, dengan tugas khusus berjudul ldquo;Reformulasi Tablet Salut Enterik Ketoprofen dan Kapsul Lepas Tunda Natrium Omeprazol di PT Novell Pharmaceutical Laboratories Periode April-Mei 2018 rdquo;. Tujuan dari pelaksanaan tugas khusus tersebut adalah untuk mendapatkan formula terbaik, sehingga sediaan memenuhi persyaratan uji disolusi terbanding dengan originatornya. Secara umum, penerapan CPOB di PT Novell Pharmaceutical Laboratories telah dilakukan dengan baik. Penulis juga mendapatkan pengetahuan dan pengalaman praktis dalam melakukan pekerjaan kefarmasian di industri farmasi, serta dapat memberikan solusi terkait permasalahan di industri farmasi.

ABSTRACT
Internship at PT Novell Pharmaceutical Laboratories aims to understand the roles, duties, and responsibilities of pharmacists in the pharmaceutical industry, and have the insight, knowledge, skills, and practical experience to undertake pharmaceutical work in the pharmaceutical industry. Pharmacist candidate can also understand the application of Good Manufacturing Practice GMP in the pharmaceutical industry, and have the representation of pharmaceutical issues in the pharmaceutical industry. Internship is carried out in the Department of Product Development, with a special assignment entitled ldquo;Reformulation of Ketoprofen Enteric Coating Tablet and Sodium Omeprazole Delayed Release Capsule at PT Novell Pharmaceutical Laboratories Period April-May 2018 . The purpose of this special assignment is to obtain the best formula, so that the product meets the comparative dissolution test requirements to the originator. In general, the application of GMP at PT Novell Pharmaceutical Laboratories has been done well. The author also gained practical knowledge and experience in doing pharmaceutical work in the pharmaceutical industry, and can provide solutions related to problems in the pharmaceutical industry."
2018
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UI - Tugas Akhir  Universitas Indonesia Library
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Andiani Wanda Putri
"Praktik kerja profesi di PT. Novell Pharmaceutical Laboratories bertujuan untuk memahami peranan, tugas, tanggung jawab Apoteker di Industri Farmasi, memiliki wawasan, pengetahuan keterampilan dan pengalaman praktis dalam melakukan pekerjaan kefarmasian di Industri Farmasi, memahami penerapan CPOB di Industri Farmasi serta memiliki gambaran nyata tentang permasalahan kefarmasian di Industri Farmasi. Praktik kerja profesi ini dilaksanakan selama delapan minggu dengan tugas khusus yaitu 'Pemeriksaan Bahan Baku Potasium Aspartat dan Validasi Metode Analisis Ibuprofen Suspensi 100 mg/5 ml'. Tujuan dari tugas khusus ini adalah agar calon apoteker memiliki wawasan, pengetahuan, keterampilan dan pengalaman praktis dalam pengembangan metode analisis di Industri armasi, mengetahui kesesuaian persyaratan bahan baku potasium aspartat dengan kompendial dan menetapkan kevalidan metode analisis penetapan kadar Ibuprofen suspensi 100 mg/5 ml.

Internship in PT. Novell Pharmaceutical Laboratories aims to understand the role, tasks, responsibilities of Pharmacists in the Pharmaceutical Industry, have insight, skills knowledge and practical experience in undertaking pharmaceutical work in the Pharmaceutical Industry, understand the application of CPOB/GMP in the Pharmaceutical Industry and have a clear picture of pharmaceutical issues in the Pharmaceutical Industry. The professional work practice is carried out for eight weeks with special tasks: Potassium Aspartate Raw Material Inspection and Validation of Analytical Methods of Ibuprofen 100 mg / 5 ml Suspension . The purpose of this particular task is to enable the prospective pharmacist to have insight, knowledge, skills and practical experience in developing analytical methods in the pharmaceutical industry, to know the suitability of potassium aspartate with compendial requirements and to determine the validity and determination of analytical method of Ibuprofen 100 mg / 5 ml suspension.
"
Depok: Fakultas Farmasi Universitas Indonesia, 2018
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UI - Tugas Akhir  Universitas Indonesia Library
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Genita Savitri Ekandari
"Praktek Kerja Profesi Apoteker dilaksanakan di PT. Novell Pharmaceutical Laboratories Jalan Pos Pengumben Raya No. 8 Jakarta Barat. Kegiatan PKPA ini bertujuan agar mahasiswa calon apoteker mengetahui dan memahami peran dan tanggungjawab Apoteker di industri farmasi khususnya dalam proses pengembangan produk obat di Departemen Business Development PT. Novell serta memahami proses pengembangan produk obat di industri farmasi sesuai dengan aturan pemerintah Indonesia. Tugas khusus yang diberikan berjudul Penyusunan Dokumen Registrasi Ulang dan Registrasi Variasi yang Terkait Registrasi Ulang untuk Obat Copy. Tugas khusus ini bertujuan agar mahasiswa mengetahui dokumen apa saja yang diperlukan dalam registrasi ulang dan registrasi variasi terkait registrasi ulang khususnya obat copy, sehingga akan mempermudah penyiapan dokumen registrasi tersebut.

Apothecary Profession Internship held in PT. Novell Pharmaceutical Laboratories Jalan Pos Pengumben Raya No. 8 Jakarta Barat. The aim of this activity is to know and understand the roles and responsibilities of pharmacist in pharmacy industry, especially in drug development process in Business Development Department (in PT. Novell), and also in Indonesia in accordance with the government regulation. The title of the specific assignment is The Arrangement of Registration Document for Renewal and Variation (associated with renewal registrasion) for Copy Drug. The aim of this task is to know all documets needed in this registrasion process, in order to simplify the preparation of the document.
"
Depok: Fakultas Farmasi Universitas Indonesia, 2014
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UI - Tugas Akhir  Universitas Indonesia Library
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