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Abstrak :
ABSTRAK
Praktik kerja profesi di PT. Guardian Pharmatama Periode Bulan Juli - Agustus 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 yaitu berjudul ldquo;Validasi Proses Tablet Unalium 10 mg Flunarizin HCl rdquo;. Tujuan dari tugas khusus ini adalah mengetahui tahapan validasi proses, parameter kritis dalam tahapan proses dan cara pengambilan sampel dalam validasi proses rdquo;. Secara umum, PT. Guardian Pharmatama 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.

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ASBTRACT
Internship at PT. Guardian Pharmatama month period July - August 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;Process Validation of Unalium 10 mg Tablet Flunarizin HCl rdquo;. The purpose of this special assignment is to know the stages of process validation, critical parameters in the process stages and how to sample in the validation process. In general, PT. Guardian Pharmatama has applied 12 aspects of GMP well and correctly, the authors also have the ability to understand the roles, duties, insights and responsibilities of pharmacists and provide solutions on products in the industry pharmacy

Abstrak :
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.

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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.

Abstrak :
Praktek Kerja Profesi Apoteker di PT. Fonko International Pharmaceuticals bertujuan untuk memahami peran serta tanggung jawab Apoteker di industry farmasi, peran serta tanggung jawab transfer proses dan produk obat di Departemen Technical Service PT. Fonko International Pharmaceuticals, serta memahami proses pengembangan produk obat di industry farmasi sesuai dengan aturan pemerintah Indonesia. Tugas Khusus yang diberikan berjudul Pembuatan Dokumen Working Instruction Panduan Pelaksanaan Validasi Proses PT. Fonko International Pharmaceuticals. Tujuan penyusunan tugas khusus ini adalah memahami cara menyusun Working Instruction Panduan Pelaksanaan Validasi Proses dan memahamiaspek-aspek penting yang perlu diperhatikan dalam penyusunan Working Instruction Panduan Pelaksanaan Validasi Proses. ...... Internship at PT. Fonko International Pharmaceuticals on July September 2016 has aims to understand the role and responsibilities of pharmacist in the pharmaceutical industry, roles and responsibilities for the product and process transfer of medicinal products in the Department of Technical Service, PT. Fonko International Pharmaceuticals, as well as understand the process of development of medicinal products in the pharmaceutical industry in accordance with the rules of the Indonesian government. Special task given entitled ldquo Creating Working Instruction Document of Process Validation Implementation Guide at PT. Fonko International Pharmaceuticals rdquo . The purpose of the main task is to understand how to create Working Instruction Document of Process Validation Implementation Guide and understand the important aspects that need to be considered to create Working Instruction Document of Process Validation Implementation Guide.

Abstrak :
Salah satu upaya yang dilakukan oleh industri farmasi untuk menjamin mutu, khasiat, dan keamanan obat adalah dengan menerapkan pedoman Cara Pembuatan Obat yang Baik CPOB . Industri Farmasi memiliki tiga personil kunci, yaitu kepala bagian produksi, kepala bagian pengawasan mutu, dan kepala bagian pemastian mutu yang harus dijabat oleh Apoteker. Praktik Kerja Profesi Apoteker PKPA yang dilaksanakan di PT Konimex bertujuan untuk memahami peran, tugas, dan tanggung jawab Apoteker di industri farmasi, serta memahami penerapan CPOB di PT Konimex. PT Konimex secara keseluruhan telah menerapkan prinsip CPOB dengan baik. Tugas khusus yang diberikan berupa penyusunan protokol validasi proses produk Heltiskin dan Konigen Cream. Secara keseluruhan, protokol validasi proses telah seseuai dengan ketentuan yang direkomendasikan dalam POP CPOB dan Guidance for Industry Process Validation: General Principles and Practices FDA. ...... Pharmaceutical industry should implements GMP guideline to ensure the quality, efficacy, and safety of the product. Pharmaceutical industry has three key personnel as head of production, head of quality control, and head of quality assurance which are pharmacist. Apothecary internship at PT Konimex aims to understand the role of pharmacist and the implementation of GMP guideline at PT Konimex. Overall, PT Konimex has implement every aspect of the GMP guideline so well. Special task given was arrangement of process validation protocol of Heltiskin and Konigen Cream. Overall, the process validation protocol has fulfilled the POP CPOB and Guidance for Industry Process Validation General Principles and Practices FDA recommendation.