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Irena Ulya
"ABSTRAK
Praktik kerja profesi di PT. Medifarma Laboratories periode bulan Agustus-September tahun 2017 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 selama delapan minggu yaitu berjudul Efisiensi Proses Changeover pada Tahap Cleaning Menggunakan Metode Single Minute Exchange of Dies (SMED). Tujuan dari tugas khusus ini agar dapat memahami dan menerapkan Operational Excellence pada departemen Produksi dengan melakukan Continuous Improvement menggunakan metode Single Minute Exchange of Dies (SMED) pada proses Pencampuran salah satu produk tablet

ABSTRACT
Internship at PT. Medifarma Laboratories period August-September 2017 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing 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 in eight weeks is Efficiency of Changeover Process on Cleaning Step Using Single Minute Exchange of Dies (SMED) Method. The purpose of this assingment is to know and apply Operational Excellence at Production Department by doing Continuous Improvement using Single Minute Exchange of Dies (SMED) method in Mixing process of one tablet product"
Depok: Fakultas Farmasi Universitas Indonesia, 2017
PR-Pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Iman Taufik
"ABSTRAK
Praktik Kerja Profesi Apoteker PKPA dilaksanakan di PT Medifarma Laboratories pada 18 Juli 2016 hingga 9 September 2016. Tujuan dilaksanakannya Praktik Kerja Profesi di Industri Farmasi PT Medifarma Laboratories agar calon Apoteker mampu memahami 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 GMP/CPOB di Industri Farmasi serta memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Kegiatan yang dilakukan selama praktik kerja profesi di PT Medifarma Laboratories meliputi pemberian materi basic GMP, safety induction, profil perusahaan dan struktur organisasi perusahaan, plan tour, induction tiap-tiap departemen di PT Medifarma Laboratories, penempatan di Departemen Pengawasan Mutu, pengerjaan tugas khusus berupa perbaikan berkelanjutan, dan presentasi akhir. Kata Kunci : Industri Farmasi, Medifarma Laboratories, Praktik Kerja Profesixiii 78 : 37 LampiranReferensi : 11 2007 - 2016
ABSTRACT
Internship at PT Medifarma Laboratories was started on July, 18th 2016 to September, 09th 2016. This internship was intended to make Apothecary student understand roles and responsibilities of Pharmacist in Pharmaceutical Industry to get insights, knowledges, skills, and practical experience to perform pharmaceutical practice understand to apply of GMP in Pharmaceutical Industry, and to gets an overview about pharmaceutical practice issues in Pharmaceutical Industry. Activity at PT Medifarma Laboratories were basic GMP materials, safety induction, profile of the company and organization structure, plan tour, induction at department at PT Medifarma Laboratories, placement at Quality Control Department, continuous improvement for special assignment and final presentation. Keywords Pharmaceutical Industry, Medifarma Laboratories, Profession Internshipxiii 78 37 AppendicesBibliography 11 2007 2016 "
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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Talogo, Adina Siti Maryam
"ABSTRAK
Praktek Kerja Profesi PKP di industri farmasi dilaksanakan PT Medifarma Laboratories Kegiatan ini berlangsung selama delapan minggu dari tanggal 30 Juni sampai dengan tanggal 24 Agustus 2015 PKP di apotek bertujuan agar mahasiswa apoteker mengerti peranan apoteker tugas dan tanggung jawab apoteker memiliki wawasan pengetahuan keterampilan dan pengalaman praktis untuk melakukan pekerjaan kefarmasian memahami penerapan Cara Pembuatan Obat dengan Baik di Industri Farmasi dan memiliki gambaran nyata tentang permasahalan pekerjaan kefarmasian di Industri Farmasi Sebelum ditempatkan pada masing masing departemen untuk melaksanakan kegiatan PKPA mahasiswa PKPA diberikan pengetahuan berupa gambaran yang meliputi kegiatan dan tugas masing masing departemen yang ada di PT Medifarma Laboratories yaitu Quality Assurance Pemastian Mutu Quality Control Pengawasan Mutu Manufacturing Technology Unit Produksi Engineering HSSE Health Safety Security and Environment dan Logistik Berdasarkan kegiatan PKP yang dilakukan dapat disimpulkan bahwa peran apoteker penting untuk menghasilkan obat obatan yang aman bermutu dan berkhasiat Berdasarkan pengamatan PT Medifarma telah menerapkan seluruh aspek CPOB dengan baik Contoh masalah di PT Medifarma Laboratories adalah target produksi yang sering mengesampingkan standar CPOB baik itu dari urutan validasi personalia sanitasi dan hygiene ABSTRACT Profession Internship n the pharmaceutical industry held by PT Medifarma Laboratories This activity was held for eight weeks from June 30th until August 24th 2015 Profession internship at pharmaceutical industry was intended to make students understand the role of the pharmacist duties and responsibilities of pharmacists has the insight knowledge skills and practical experience to do the job pharmacy understand the implementation of the Good Manufacturing Practice in the Pharmaceutical Industry and have a real picture about the problems of pharmaceutical jobs in the Pharmaceutical Industry Before being placed in each department to carry out the activities PKPA PKPA students are given the knowledge in the form of a picture that includes activities and tasks for each department in the PT Medifarma Laboratories the Quality Assurance Quality assurance Quality Control Quality Control Manufacturing Technology Unit Production Engineering HSSE Health Safety Security and Environment and Logistics Based on PFM activities undertaken it can be concluded that the role of the pharmacist is important to produce medicines that are safe quality and berkhasiat Berdasarkan observations PT Medifarma have implemented all aspects of GMP well Examples of problems in PT Medifarma Laboratories is a frequent target of production of GMP standard rule out either of the order validation personnel sanitation and hygiene ;Profession Internship n the pharmaceutical industry held by PT Medifarma Laboratories This activity was held for eight weeks from June 30th until August 24th 2015 Profession internship at pharmaceutical industry was intended to make students understand the role of the pharmacist duties and responsibilities of pharmacists has the insight knowledge skills and practical experience to do the job pharmacy understand the implementation of the Good Manufacturing Practice in the Pharmaceutical Industry and have a real picture about the problems of pharmaceutical jobs in the Pharmaceutical Industry Before being placed in each department to carry out the activities PKPA PKPA students are given the knowledge in the form of a picture that includes activities and tasks for each department in the PT Medifarma Laboratories the Quality Assurance Quality assurance Quality Control Quality Control Manufacturing Technology Unit Production Engineering HSSE Health Safety Security and Environment and Logistics Based on PFM activities undertaken it can be concluded that the role of the pharmacist is important to produce medicines that are safe quality and berkhasiat Berdasarkan observations PT Medifarma have implemented all aspects of GMP well Examples of problems in PT Medifarma Laboratories is a frequent target of production of GMP standard rule out either of the order validation personnel sanitation and hygiene ;Profession Internship n the pharmaceutical industry held by PT Medifarma Laboratories This activity was held for eight weeks from June 30th until August 24th 2015 Profession internship at pharmaceutical industry was intended to make students understand the role of the pharmacist duties and responsibilities of pharmacists has the insight knowledge skills and practical experience to do the job pharmacy understand the implementation of the Good Manufacturing Practice in the Pharmaceutical Industry and have a real picture about the problems of pharmaceutical jobs in the Pharmaceutical Industry Before being placed in each department to carry out the activities PKPA PKPA students are given the knowledge in the form of a picture that includes activities and tasks for each department in the PT Medifarma Laboratories the Quality Assurance Quality assurance Quality Control Quality Control Manufacturing Technology Unit Production Engineering HSSE Health Safety Security and Environment and Logistics Based on PFM activities undertaken it can be concluded that the role of the pharmacist is important to produce medicines that are safe quality and berkhasiat Berdasarkan observations PT Medifarma have implemented all aspects of GMP well Examples of problems in PT Medifarma Laboratories is a frequent target of production of GMP standard rule out either of the order validation personnel sanitation and hygiene ;Profession Internship n the pharmaceutical industry held by PT Medifarma Laboratories This activity was held for eight weeks from June 30th until August 24th 2015 Profession internship at pharmaceutical industry was intended to make students understand the role of the pharmacist duties and responsibilities of pharmacists has the insight knowledge skills and practical experience to do the job pharmacy understand the implementation of the Good Manufacturing Practice in the Pharmaceutical Industry and have a real picture about the problems of pharmaceutical jobs in the Pharmaceutical Industry Before being placed in each department to carry out the activities PKPA PKPA students are given the knowledge in the form of a picture that includes activities and tasks for each department in the PT Medifarma Laboratories the Quality Assurance Quality assurance Quality Control Quality Control Manufacturing Technology Unit Production Engineering HSSE Health Safety Security and Environment and Logistics Based on PFM activities undertaken it can be concluded that the role of the pharmacist is important to produce medicines that are safe quality and berkhasiat Berdasarkan observations PT Medifarma have implemented all aspects of GMP well Examples of problems in PT Medifarma Laboratories is a frequent target of production of GMP standard rule out either of the order validation personnel sanitation and hygiene "
Fakultas Farmasi Universitas Indonesia, 2016
PR-PDF
UI - Tugas Akhir  Universitas Indonesia Library
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Asrika Mutiara
"ABSTRAK
Praktek Kerja Profesi Apoteker PKPA dilaksanakan di PT. Medifarma Laboratories pada 18 Juli 2016 hingga 9 September 2016. Tujuan dilaksanakannya Praktek Kerja Profesi di Industri Farmasi agar calon Apoteker mampu 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; dan memiliki gambaran nyata tentang permasalahan pekerjaan kefarmasian di Industri Farmasi. Kegiatan yang dilakukan selama praktek kerja profesi di PT. Medifarma Laboratories meliputi pemberian materi basic GMP, safety induction, profil perusahaan dan struktur organisasi perusahaan, plan tour, induction masing-masing departemen di PT. Medifarma Laboratories, penempatan di Departemen Engineering, pengerjaan tugas khusus berupa perbaikan berkelanjutan, dan presentasi akhir.

ABSTRACT
Internship at PT. Medifarma Laboratories was started on July, 18th 2016 to September , 09th 2016. This internship was intended to make Apotechary student understand roles and responsibilities of apotechary in Pharmaceutical Industry to get insights, knowledges, skills, and practical experience to perform pharmaceutical practice understand to apply CPOB in Pharmaceutical Industry and to gets an overview about pharmaceutical practice issues in Pharmaceutical Industry. Activities at PT. Medifarma Laboratiries were basic GMP materials, safety induction, profile of the company and organization structure, plan tour, induction at each of departement at PT. Medifarma Laboratories, placement at Engineering Departement, continous improvement for special assigment and final presentation. "
2017
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Fitria Ramadhani
"ABSTRAK
Industri farmasi adalah badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Industri farmasi wajib memenuhi persyaratan Cara Pembuatan Obat yang Baik CPOB . Praktek Kerja Profesi PKP di PT. Medifarma Laboratories dilakukan pada tanggal 1 Februari ndash; 31 Maret 2017. Tujuan pelaksanaan PKP untuk memperoleh gambaran dan pengalaman mengenai peran profesi apoteker di industri farmasi, khususnya dalam bidang pemastian mutu. Kegiatan yang dilakukan selama PKP antara lain pengenalan secara umum mengenai PT. Medifarma Laboratories; induksi ke departemen yang berkaitan dengan pekerjaan kefarmasian yaitu Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic, dan membantu pekerjaan di Departemen QA seperti memeriksa dokumen untuk pelolosan produk jadi, dan membuat dokumen registrasi salah satu produk Medifarma. Medifarma Laboratories merupakan salah satu industri farmasi yang telah menerapkan pedoman CPOB dalam setiap kegiatan yang dilakukan, baik dalam proses produksi, pengawasan dan pemastian mutu, serta kegiatan lain yang terkait.

ABSTRACT
Pharmaceutical industry is a corporation that has a license from Minister of Health to manufacturing of drugs or drug materials. Pharmaceutical industry is obliged to comply with the requirements of Good Manufacturing Practice for Pharmaceuticals GMP . Profession internship at PT. Medifarma Laboratories held on February 1st to March 31st 2017. The aim of profession internship to obtain an overview and experience of professional role of pharmacists in pharmaceutical industry, particularly in a quality assurance. Activities conducted during profession internship among other general introduction about PT. Medifarma Laboratories induction into department which related pharmacy that are Quality Assurance QA , Quality Control QC , Engineering, Production, Health Safety Environment HSE , Manufacturing Technology Unit MTU , logistic and help the task at QA Department such as review document for finish good release and making dossier for registration one of product in PT.Medifarma Laboratories. PT. Medifarma Laboratories is the one of pharmaceutical industry which has implemented the GMP guidelines in each of activities, both in production process, control and quality assurance, and other related activities. "
2017
PR-pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Deni Lastanto
"ABSTRAK
Praktik kerja profesi di PT. Medifarma Laboratories Periode Bulan Agustus-September 2017 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 ldquo;Value Stream Mapping Produk Jadi rdquo;. Tujuan dari tugas khusus ini adalah mengidentifikasi waste dan akar penyebab waktu tunggu proses pengiriman produk jadi dan penumpukan produk jadi di secondary packaging, staging area dan warehouse, serta mengusulkan ide continous improvement untuk mengurangi waktu tunggu dan penumpukan produk jadi di secondary packaging, staging area, dan warehouse.

ABSTRACT
Internship at PT. Medifarma Laboratories month period August-September 2017 aims to understand the duties and responsibilities of pharmacists in the pharmaceutical industry and the understanding of the application of good manufacturing 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 ldquo;Value Stream Mapping of Finished Goods rdquo;. The purpose of this special assignment is to identify waste and root cause of lead time of finished product delivery and accumulation of finished product in secondary packaging, staging area and warehouse, and propose continous improvement idea to reduce lead time and accumulation of finished product in secondary packaging, staging area and warehouse "
2017
PR-Pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Sulistiyaningsih
"ABSTRAK
Praktek Kerja Profesi (PKP) di Industri PT. Medifarma Laboratories bertujuan agar calon apoteker memiliki wawasan, pengetahuan, keterampilan, dan pengalaman dalam melakukan pekerjaan kefarmasian, kemudian agar dapat memahami penerapan Cara Pembuatan Obat yang Baik (CPOB) di industri dan gambaran nyata permasalahan yang dapat terjadi. PKP dilakukan selama 2 bulan dengan mempelajari sebagian departemen industri dan secara khusus di departemen Quality Control untuk melakukan tugas khusus. Tujuan dari pelaksanaan tugas khusus yaitu meningkatkan efisiensi membran filter pada
penyaringan fase gerak untuk analisa di Kromatografi Cair Kinerja Tinggi (KCKT) dan menilai parameter yang berkaitan dengan penggunaan membran filter berulang. Peran apoteker dalam industri farmasi yaitu berada di posisi kunci meliputi produksi, Quality Control dan Quality Assurance. Penerapan CPOB diperoleh mahasiswa dengan mengikuti training basic GMP dan penjelasan setiap departemen.

ABSTRACT
Profession internship at PT. Medifarma Laboratories company aims pharmacist
candidate has knowledge, skill, and experience for doing pharmacist jobs, then to know the implementation Good Manufacturing Product (GMP) in pharmaceuticals industry and to face the real working world the problem that
could be held. Profession internship was held during two months which studied a lot of section on the company and Quality Control specifically. Given special
assignment in QC department which is about membrane filter. The aims to
increase the efficiency membrane filter on the mobile phase filtration for
analyzing in High Performance Liquid Chromatography (HPLC) and to give a
value on the parameter which is related with the usage membrane filter usage. The role of pharmacist in pharmaceutical industry is key position on production, Quality Control and Quality Assurance department. The implementation of GMP which is get with joining GMP training basic and the explanation every department."
2016
PR-Pdf
UI - Tugas Akhir  Universitas Indonesia Library
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Subhan Asfari
"ABSTRAK
Industri farmasi merupakan salah satu sarana tempat dilakukan pekerjaan kefarmasian. Praktik kerja profesi yang dilaksanakan di PT Medifarma Laboratories ini, bertujuan agar mahasiswa mendapatkan pengalaman nyata dalam melakukan pekerjaan kefarmasian di industri farmasi. Industri farmasi adalah badan usaha yang memiliki izin untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam pembuatan obat, industri farmasi harus memenuhi ketentuan Cara Pembuatan Obat yang Baik CPOB agar obat yang dihasilkan aman, berkhasiat dan bermutu. Seluruh aspek CPOB telah diterapkan oleh PT Medifarma Laboratories. Selain itu, PT Medifarma Laboratories juga menerapkan ketentuan GMP dari PIC/s sebagai jaminan tambahan untk keperluan ekspor produk. Seluruh proses produksi dan aspek terkait telah dikendalikan, dan setiap tahapnya telah terdokumentasikan. Salah satu upaya pengendalian dalam proses produksi adalah validasi proses yang menjadi tugas khusus yang diberikan kepada mahasiswa. Validasi proses merupakan usaha untuk membangun bukti terdokumentasi bahwa suatu proses produksi akan senantiasa menghasilkan produk yang memenuhi kriteria yang ditentukan. Validasi ini termasuk dalam validasi konkuren, dilakukan terhadap pada tiga bets tablet suplemen XYZ berturut-turut, dimana tiap bets berukuran 100.000 tablet. Validasi proses telah dilakukan mulai dari tahap wet compounding, dry mixing, compression dan coating. Validasi terhadap proses blistering tablet suplemen XYZ juga telah dilakukan. Dari hasil validasi, disimpulkan bahwa proses produksi tiga bets tablet suplemen XYZ telah tervalidasi.

ABSTRACT
The pharmaceutical industry is one of the places to do the pharmaceutical works. The internship that held at PT Medifarma Laboratories, intended to make students get the real experience in performing the pharmaceutical works in the pharmaceutical industry. The pharmaceutical industry is an entity that has a license to conduct the manufacture of drugs or drug ingredients. In the manufacture of drugs, the pharmaceutical industry must comply Good Manufacturing Practice GMP so that the resulting drug meet the criteria of safe, efficacy and quality. All aspects of GMP has been applied by PT Medifarma Laboratories. In addition, PT Medifarma Laboratories also applying the GMP provisions of PIC s as an additional guarantee for export products. The whole process of production and its related aspects are controlled, and every stage is documented. One of the actions in order to control the production process is validation process that became task given to the student. The validation process is establishing documented evidence to determine that process consistently produce a product meet its predetermined specifications and quality characteristics. Validation that had been done is classified as concurrent validation, and were carried out on three batches of Tablet Supplements XYZ, where the size of each batch were 100.000 tablets. Validation process were started from wet compounding, dry mixing, compression, and coating. Validation of the blistering process Tablets Supplement XYZ had also been performed. The results showed that the production process of three batches of Tablet Supplements XYZ had been validated."
Depok: Fakultas Farmasi Universitas Indonesia, 2017
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UI - Tugas Akhir  Universitas Indonesia Library
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