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Alifa Aprilia Listiyani
"[Berdasarkan Peraturan Menteri Kesehatan Republik Indonesia Nomor 1799 Menkes Per XII 2010 proses pembuatan obat dan atau bahan obat hanya dapat dilakukan oleh Industri Farmasi yakni badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat Pada pelaksanaannya industri farmasi harus menerapkan Cara Pembuatan Obat yang Baik CPOB yang bertujuan untuk menjamin obat dibuat secara konsisten memenuhi persyaratan yang ditetapkan dan sesuai dengan tujuan penggunaannya CPOB terdiri atas 12 pilar yang CPOB mencakup seluruh aspek produksi dan pengendalian mutu Pada pembuatan obat pengendalian secara menyeluruh merupakan hal yang sangat esensial untuk menjamin bahwa konsumen menerima obat yang bermutu tinggi Praktek Kerja Profesi Apoteker yang dilaksanakan di PT Gratia Husada Farma HUFA telah memberikan pemahaman bahwa Apoteker dapat berperan penting di industri farmasi yakni dalam hal manajemen teknis saat pelaksanaan produksi dan pengawasan Selain itu apoteker juga dapat berperan dalam pengembangan produk perencanaan produksi serta penyimpanan barang Kegiatan PKPA ini diharapkan dapat meluluskan calon Apoteker yang berkualitas dan berdaya saing tinggi sehingga dapat menerapkan current Good Manufacturing Practice cGMP untuk menghasilkan produk yang memenuhi syarat Quality Safety dan Efficacy QSE ;Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE ;Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE , Based on the Regulation of the Minister of Health of the Republic of Indonesia Number 1799 Menkes Per XII 2010 the manufacturing process of drugs and or drug ingredients only be carried out by the Pharmaceutical Industry the business entity that has a license from the Minister of Health to conduct the manufacture of drugs or drug ingredients In practice the pharmaceutical industry must implement the Good Manufacturing Practice GMP which aims to ensure the drugs are made consistently meet the requirements set and in accordance with the intended use GMP consists of 12 pillars that covers all aspects of production and quality control In the manufacture of drugs overall control is very essential to ensure that consumers receive high quality drugs Apothecary Profession Profession PKPA conducted at PT Gratia Husada Farma HUFA has given the understanding that pharmacists can play an important role in the pharmaceutical industry in terms of management current technical production implementation and supervision In addition pharmacists can also play a role in product development production planning as well as the storage of goods PKPA activity is expected to pass Pharmacists qualified candidates and competitive so as to apply the current Good Manufacturing Practice cGMP to produce products that meet the requirements of Quality Safety and Efficacy QSE ]"
Depok: Fakultas Farmasi Universitas Indonesia, 2015
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UI - Tugas Akhir  Universitas Indonesia Library
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Ghina Ashiila Amalia
"Praktik kerja profesi di PT Gratia Husada Farma Periode Bulan Februari ndash; Maret Tahun 2018 bertujuan untuk mengetahui tugas dan tanggung jawab apoteker di industri farmasi dan memahami penerapan Cara Pembuatan Obat yang Baik CPOB di Industi Farmasi. Selain itu calon apoteker juga dapat memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi, memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi. Tugas khusus yang diberikan yaitu berjudul "Perencanaan Kapasitas Mesin Produksi Sediaan Farmasi dengan Analisis Downtime Mesin". Tujuan dari pelaksanaan tugas khusus di PT Gratia Husada Farma adalah meningkatkan kapasitas mesin produksi berdasarkan hasil pengamatan downtime mesin. Secara umum, PT Gratia Husada Farma telah menerapkan 12 aspek CPOB dengan baik dan benar, penulis juga telah mendapatkan kemampuan untuk memahami peran, tugas, wawasan dan tanggung jawab apoteker dan memberikan solusi pada permasalahan di industri farmasi.

Internship at PT Gratia Husada Farma Plant Period February - March 2018 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of goodmanufacturing practice GMP in the pharmaceutical industry. In addition, the pharmacist candidate can also have the insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry. The special assignment given is "Pharmaceutical Production Machine Capacity Planing Through Downtime Analysis". The purpose of this special assignment is to improve the production machine capacity based on the downtime analysis. In general, PT Gratia Husada Farma has applied authors also have the ability to responsibilities of pharmacists and pharmacy 12 aspects of GMP well and correctly, the understand the roles, duties, insights and provide solutions on products in the industry.
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Depok: Fakultas Farmasi Universitas Indonesia, 2018
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UI - Tugas Akhir  Universitas Indonesia Library
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Kartika Dwi Sukmawati
"Praktik kerja profesi sebagai apoteker industri dilakukan di PT Gratia Husada Farma bertujuan untuk memberikan pemahaman peranan, tugas, dan tanggung jawab apoteker di industri farmasi, memberikan wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di industri farmasi, memberikan pemahaman terhadap penerapan Cara Pembuatan Obat yang Baik CPOB di industri farmasi, serta memberikan gambaran nyata mengenai permasalahan pekerjaan kefarmasian di industri farmasi. Praktik kerja dilakukan selama dua bulan yang memberikan kesempatan kepada mahasiswa untuk terlibat langsung dalam seluruh tahapan yang dilakukan di industri farmasi. Mahasiswa diberikan tugas khusus dengan judul "Perencanaan Kapasitas Mesin Produksi Sediaan Farmasi dengan Analisis Downtime Mesin". Tujuan dari tugas khusus tersebut adalah menentukan downtime mesin produksi yang terjadi selama waktu operasional saat pengamatan dan menentukan jumlah output yang dapat ditingkatkan melalui analisis downtime mesin produksi.

Internship as an industry pharmacist conducted at PT Gratia Husada Farma aims to provide an understanding of the role, duties and responsibilities of pharmacists in the pharmaceutical industry, providing insight, knowledge, skills and practical experience to undertake pharmaceutical work in the pharmaceutical industry, applying Good Manufacturing Practices GMP in the pharmaceutical industry, as well as provide a clear picture of the pharmaceutical work pharmaceutical industry. The internship is conducted for two months giving students the opportunity to be directly involved in all phases in the pharmaceutical industry. Students are given a special assignment entitled Planning Capacity of Pharmaceutical Production Machinery with Downtime Analysis of Machine. The purpose of this particular assignment is to determine the downtime of the production machine during the operational time during observation and to determine the amount of output that can be increased through the analysis of production machine downtime.
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Depok: Fakultas Farmasi Universitas Indonesia, 2018
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UI - Tugas Akhir  Universitas Indonesia Library
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Amanda Listiyani
"ABSTRAK
Industri Farmasi memiliki peran strategis dalam usaha pelayanan kesehatan kepada masyarakat. Proses pembuatan obat maupun penggunaan bahan obat hanya dapat dilakukan oleh badan usaha yang telah memiliki izin, yakni Industri Farmasi. Industri farmasi dituntut untuk terus meningkatkan kuantitas dan kualitas obat dengan adanya penerapan CPOB Cara Pembuatan Obat yang Baik . membuat Sumber daya manusia personalia yang memegang peranan penting di Industri Farmasi adalah Apoteker. Melalui Praktek Kerja Profesi Apoteker PKPA , Apoteker dituntut untuk mempunyai wawasan, pengetahuan dan pengalaman praktis yang memadai serta kemampuan dalam memimpin agar dapat mengatasi permasalahan permasalahan yang ada di industri farmasi. Praktik Kerja Profesi ini dilakukan selama dua bulan di PT Gratia Husada Farma HUFA , Semarang. Setelah melakukan praktik kerja profesi, Apoteker mengetahui tugas dan tanggung jawab Apoteker di bidang managerial maupun operasional. Memiliki ketrampilan seperti pembuatan pengkajian mutu produk, mengikuti alur proses produksi, serta mengetahui masalah terkait manajemen personil, operasional, mesin dan biaya

ABSTRACT
Pharmaceutical Industry has strategic role in health services to the community. Medicine or medicinal materials manufacturing process, only can be done by licensed business entity, in this case is the pharmaceutical industry. Pharmaceutical industry is in charge to keep their quantity and quality with GMP Good Manufacturing Process implementation. Human resources personalia that play important role in the pharmaceutical industry was the Pharmacist. By internship at PT Gratia Husada Farma, Pharmacist is in charge to have adequate insight, knowledge, dan practical experience, and also ability to guide in order to overcome the problems that exist in the pharmaceutical industry. This internship was done for two months at PT Gratia Husada Farma HUFA , Semarang. After the internship, the Pharmacist knew their duty and responsibility in managerial and operational area. Having skills such as making product quality review, following production process, and also knew related issues about personalia, operational, machine and budgeting management "
Depok: Fakultas Farmasi Universitas Indonesia, 2017
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UI - Tugas Akhir  Universitas Indonesia Library
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Putri Sari
"ABSTRAK
Perkembangan dunia kesehatan terutama obat semakin berkembang seiring berjalannya waktu. Harapan masyarakat terhadap kualitas dan keamanan obat juga menjadi lebih tinggi. Industri farmasi memiliki peran dan tanggung jawab terbesar terkait efikasi, keamanan, kualitas dan mutu obat. Dalam penerapan CPOB di industri farmasi, apoteker memegang peran yang penting terutama dalam tugas produksi, pengawasan mutu dan pemastian mutu yang harus dipimpin oleh seorang apoteker. Oleh sebab itu mahasiswa calon apoteker harus berkompeten serta menguasai pengetahuan dan keterampilan yang baik untuk dapat menerapkan CPOB di dalam industri farmasi. Pengetahuan yang didapat mahasiswa selama praktek kerja profesi PT Gratia Husada Farma terkait pekerjaan kefarmasian di industri farmasi, seperti memahami pengembangan obat baru atau trial dan metode pengujiannya, mengikuti alur penerimaan, pengeluaran dan penyimpanan bahan awal dan produk jadi, alur proses produksi obat dan manajemennya, sistem penunjang, dan pengawasan serta penjaminan mutu.

ABSTRACT
The development of health care and technology, especially drugs, has grown over time. Public expectations of drug quality and safety are also higher. The pharmaceutical industry has the greatest roles and responsibilities related to the efficacy, safety and quality of the drug. In the application of GMP in the pharmaceutical industry, pharmacists have an important role especially in the task of production, quality control and quality assurance that must be led by a pharmacist. Therefore, pharmacist students must be competent and have good knowledge and skills to do the GMP in the pharmaceutical industry. Knowledge gained by student during the professional practice in PT Gratia Husada Farma Semarang is all related to pharmaceutical practice in the pharmaceutical industry, such as understanding the development of new drugs or trials and test methods, knowing the flow of acceptance and storage of raw materials and finished products, the flow of the drug production process and its management, the support systems, the quality control and quality assurance"
2017
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UI - Tugas Akhir  Universitas Indonesia Library
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Anggun Pramuda Wardhani
"[ABSTRAK
Praktik Kerja Profesi dilaksanakan di PT. Medifarma Laboratories yang
berlangsung pada periode 01 Februari ? 30 Maret 2015. Kegiatan PKP ini
bertujuan agar mahasiswa profesi apoteker dapat melihat langsung kegiatan di
industri farmasi, memperoleh pengetahuan dan wawasan tentang segala aspek
terkait industri farmasi terutama dalam hal penerapan CPOB dan memahami
peran dan tugas apoteker di industri farmasi. Tugas khusus yang diberikan
berkaitan dengan forced degradation studi yang bertujuan untuk mengetahui
kemampuan metode analisis dalam mengukur respon analit dengan adanya
matriks sampel dan cemaran yang spesifik sehingga dapat digunakan sebagai
metode analisa rutin untuk pengujian kadar obat pada sampel stability. ABSTRACT Professional Internship was held at PT. Medifarma Laboratories on February 1st
? March 30th 2015. This Professional Internship is aimed to allow the apothecary
profession students to see directly the activity in the pharmaceutical industry, to
gain knowledge and insight at all aspects related to the pharmaceutical industry
especially in terms of the GMP implementation, and to understand the role and
duties of pharmacist in the pharmaceutical industry. The theme of special
assignment that is given is about Forced Degradation studies with the purpose of
study to determine any various degradant in drug product and to find out stability
of drug product in order to generate ore stable formulations.;Professional Internship was held at PT. Medifarma Laboratories on February 1st
? March 30th 2015. This Professional Internship is aimed to allow the apothecary
profession students to see directly the activity in the pharmaceutical industry, to
gain knowledge and insight at all aspects related to the pharmaceutical industry
especially in terms of the GMP implementation, and to understand the role and
duties of pharmacist in the pharmaceutical industry. The theme of special
assignment that is given is about Forced Degradation studies with the purpose of
study to determine any various degradant in drug product and to find out stability
of drug product in order to generate ore stable formulations.;Professional Internship was held at PT. Medifarma Laboratories on February 1st
? March 30th 2015. This Professional Internship is aimed to allow the apothecary
profession students to see directly the activity in the pharmaceutical industry, to
gain knowledge and insight at all aspects related to the pharmaceutical industry
especially in terms of the GMP implementation, and to understand the role and
duties of pharmacist in the pharmaceutical industry. The theme of special
assignment that is given is about Forced Degradation studies with the purpose of
study to determine any various degradant in drug product and to find out stability
of drug product in order to generate ore stable formulations., Professional Internship was held at PT. Medifarma Laboratories on February 1st
– March 30th 2015. This Professional Internship is aimed to allow the apothecary
profession students to see directly the activity in the pharmaceutical industry, to
gain knowledge and insight at all aspects related to the pharmaceutical industry
especially in terms of the GMP implementation, and to understand the role and
duties of pharmacist in the pharmaceutical industry. The theme of special
assignment that is given is about Forced Degradation studies with the purpose of
study to determine any various degradant in drug product and to find out stability
of drug product in order to generate ore stable formulations.]"
Fakultas Farmasi Universitas Indonesia, 2015
PR-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Millatur Rodiyah
"[ABSTRAK
Praktek Kerja Profesi (PKP) di PT Kimia Farma Tbk. Unit Research and Development dilaksanakan pada periode 2 Februari - 13 Maret 2015, bertujuan agar mahasiswa calon apoteker mengerti peranan, tugas, dan tanggung jawab Apoteker di industri farmasi khususnya di PT Kimia Farma Tbk. Unit Research and Development, memahami penerapan CPOB di industri farmasi, dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di industri farmasi. Pada PKP ini juga diberikan tugas khusus yaitu berupa studi preformulasi dan formulasi tablet vitamin K3 (Menadion Natrium Bisulfit) 10 mg.

ABSTRACT
Profession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg., Profession Internship (PKP) at PT Kimia Farma Tbk. Research and Development Unit on February 2nd - March 13th 2015, aims to make students understand about the role of the prospective, duties, and responsibilities of pharmacist in pharmaceutical industries specifically in PT. Kimia Farma Tbk. Research and Development Unit, understanding the application of GMP in the in pharmaceutical industries, and have a real picture about the problem of pharmaceutical jobs in pharmaceutical industries. The special assignment of this PKP was preformulation and formulation study of Tablets Vitamine K3 (Menadione Sodium Bisulfite) 10 mg.]"
2015
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UI - Tugas Akhir  Universitas Indonesia Library
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Jennifer Christie
"Industri Farmasi merupakan badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Setiap industri, baik industri dalam negeri maupun industri luar negeri yang akan memasarkan produknya di Indonesia harus melalui proses registrasi terlebih dahulu di BPOM atau KemenKes untuk mendaftarkan produknya. Dalam pelaksanaan prosedur pendaftaran atau registrasi tersebut, industri terkait dalam hal ini industri farmasi memerlukan bagian yang dapat mengetahui, mengerti, dan memahami secara jelas pelaksanaan prosedur registrasi tersebut, persyaratan yang diperlukan, dan peraturan perundang-undangan terkait. Regulatory Affairs merupakan bagian tersebut dan menjadi penghubung antara pihak industri dengan pihak pemerintah dalam hal ini BPOM dan KemenKes. Apoteker sebagai salah satu tenaga kesehatan profesional, tentunya berperan di Regulatory Affairs karena salah satu tanggung jawab seorang apoteker adalah menjamin kesehatan masyarakat. Oleh karena itu, calon apoteker perlu diberikan pembekalan ilmu dan informasi yang lebih mendalam mengenai Regulatory Affairs sehingga memahami tentang tugas dan fungsinya.
Tujuan dari praktek kerja profesi ini adalah mengetahui peranan, tugas, dan tanggung jawab apoteker di Industri Farmasi; memiliki wawasan, pengetahuan, keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian di Industri Farmasi khususnya di bagian Regulatory Affairs; memahami mekanisme pendaftaran atau registrasi produk, baik obat, produk biologi, obat tradisional, pangan, kosmetika, serta alat kesehatan dan perbekalan kesehatan rumah tangga. Peran apoteker di bagian Regulatory Affairs adalah melakukan proses pendaftaran produk dimulai dari menyiapkan dan menyusun seluruh dokumen sesuai yang dipersyaratkan hingga menyerahkan dokumen pendaftaran ke pihak regulator.

Pharmaceutical industy is a business entity that has a license from the Minister of Health to conduct the manufacture of medicines or medicines ingredients. Every industry, both domestic and foreign which will market its products in Indonesia must go through the registration process prior to BPOM or the Ministry of Health to register their products. In the implementation of the registration procedure, pharmaceutical industry requires division to understand the implementation of the registration procedure, the necessary requirements, and related regulation. Regulatory Affairs is the part and be a liaison between the industry and the government institution, BPOM and the Ministry of Health. Pharmacists as one of the health professionals, play a role in Regulatory Affairs due to responsibilities of a pharmacist is to ensure public health. Therefore, pharmacists should be given a knowledge and in-depth information on Regulatory Affairs to understand their duties and functions.
The purpose of this profession internship are to understand the role, duties and responsibilities of pharmacists in the pharmaceutical industry; have the insight, knowledge, skills, and practical experience in working in the pharmaceutical industry, especially regulatory affairs; understand the registation process of products, whether medicines, biologics, traditional medicines, food, cosmetics, medical devices, home medical supplies and equipment. The role of pharmacists at the Regulatory Affairs is to register the product begins of preparing all documents as required to submit registration documents to the regulator.
"
Depok: Fakultas Farmasi Universitas Indonesia, 2016
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UI - Tugas Akhir  Universitas Indonesia Library
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Paramita Nurhuda
"ABSTRAK
Praktek Kerja Profesi di PT Actavis Indonesia bertujuan untuk mengetahui dan
memahami peran, tugas, dan tanggung jawab apoteker di industri farmasi serta
memahami penerapan Cara Pembuatan Obat yang Baik (CPOB). Selain itu,
kegiatan ini juga bertujuan agar calon apoteker memiliki wawasan, pengetahuan,
keterampilan, dan pengalaman praktis untuk melakukan pekerjaan kefarmasian
serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di
industri farmasi. Tugas khusus yang diberikan berjudul Pembuatan Periodic
Product Review (PPR) Hydrocortisone 1.0% Cream Periode 6 Oktober 2013 ? 5
Oktober 2014. Tugas khusus bertujuan untuk memahami cara pembuatan laporan
pengkajian mutu produk, khususnya di PT Actavis Indonesia yang ditinjau secara
sistematis dan dapat menggambarkan produk yang diproduksi telah memenuhi
syarat kualitas dan spesifikasi yang ditetapkan, dan mengidentifikasi tindakan
pencegahan dan perbaikan / corrective and preventive action (CAPA) terhadap
produk dan proses jika dibutuhkan. ABSTRACT Profession Internship at PT Actavis Indonesia aims to learn and understand the
duties and responsibilities of apothecary in the pharmaceutical industry as well as
understanding the application of Good Manufacturing Practice (GMP).
Additionally, this activity also aims to have the insight, knowledge, skills, and
practical experience to do the work of pharmacy and have vivid description about
the problems of pharmaceutical jobs in the pharmaceutical industry. Specific
assignment entitled Recipe Periodic Product Review (PPR) 1.0% Hydrocortisone
Cream Period October 6, 2013 - October 5, 2014 that aims to understand how to
make the Periodic Product Review (PPR), especially in PT Actavis Indonesia,
systematically and it can describe that the product fulfilled the requirements of
quality and specification; and identifying corrective and preventive action
(CAPA) for the product and process if needed. ;Profession Internship at PT Actavis Indonesia aims to learn and understand the
duties and responsibilities of apothecary in the pharmaceutical industry as well as
understanding the application of Good Manufacturing Practice (GMP).
Additionally, this activity also aims to have the insight, knowledge, skills, and
practical experience to do the work of pharmacy and have vivid description about
the problems of pharmaceutical jobs in the pharmaceutical industry. Specific
assignment entitled Recipe Periodic Product Review (PPR) 1.0% Hydrocortisone
Cream Period October 6, 2013 - October 5, 2014 that aims to understand how to
make the Periodic Product Review (PPR), especially in PT Actavis Indonesia,
systematically and it can describe that the product fulfilled the requirements of
quality and specification; and identifying corrective and preventive action
(CAPA) for the product and process if needed. "
Fakultas Farmasi Universitas Indonesia, 2015
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UI - Tugas Akhir  Universitas Indonesia Library
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Siti Khoiriah
Depok: Fakultas Farmasi Universitas Indonesia, 2016
PR-Pdf
UI - Tugas Akhir  Universitas Indonesia Library
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