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"Praktik Kerja Profesi Apoteker di PT. AstraZeneca Cikarang-Site bertujuan untuk mengetahui, memahami, dan mampu menerapkan mengenai tugas dan tanggung jawab apoteker di Industri Farmasi. Selain itu, melalui praktik kerja ini diharapkan calon apoteker memahami tentang penerapan Cara Pembuatan Obat yang Baik CPOB di Industri. Tugas khusus yang diberikan berjudul Pembuatan Kajian Mutu Produk Tahunan Annual Product Review Periode Juli 2015 ndash; Juni 2016. Tujuan penyusunan tugas khusus ini adalah untuk mengetahui dan memahami tahapan menyusun laporan kajian mutu produk tahunan Annual Product Review pada PT. AstraZeneca Indonesia-Cikarang Site periode Juli 2015-Juni 2016.

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Pharmacist internship at PT. AstraZeneca Cikarang Site aims to know and understand the role and responsibility of Pharmacist in Pharmacy Industry. In addition trough this Internship a future pharmacist also could understand the application of Good Manufacturing Practice GMP . The internship given a special assignment titled Establishment of Annual Product Review Periods of July 2015 ndash June 2016. The purposes of this particular assignment are to knowing and to understanding the establish of Annual Product Review Periods of July 2015 ndash June 2016 at PT. AstraZeneca Cikarang Site."

"ABSTRAKApoteker di industri farmasi memiliki tanggung profesi untuk memastikan bahwa mutu obat yang dihasilkan memenuhi persyaratan dan tujuan penggunaannya dengan berpedoman kepada prinsip Cara Pembuatan Obat yang Baik (CPOB).Kegiatan Praktek Kerja Profesi Apoteker (PKPA) ditujukan untuk memberikan pengalaman praktis dan gambaran nyata mengenai peran,tugas dan tanggung jawab profesi apoteker di industri farmasi.PKPA ini dilaksanakan di PT. AstraZeneca Indonesia selama dua bulan di bagian pemastian mutu dengan kegiatan utama berupa induksi materi dari berbagai departemen, mengerjakan Annual Product Review (APR), mengerjakan Corrective Action Preventive Action (CAPA) dan evidence based dari self inspection serta mengerjakan gap analysis prosedur.Induksi yang diberikan berupa penjelasan singkat mengenai tugas dan fungsi dari masing-masing departemen.APR yang dikerjakan berupa dua APR dari produk packing I MY, I TW dan I AU serta satu APR dari produk repacking Z dan B.Hasilnya, semua produk packing maupun repacking dinyatakan rilis.Penerapan CAPA dan evidence based terhadap self inspection documentation error dilakukan dengan memberikan SOP ke bagian departemen yang belum tedaftar sebelumnya.Sedangkan gap analysis dari guidline Process Trending and Robustness Analysis dengan SOP Product Review Report dan Standart Change Control in the Quality and Compliance Area serta SOP Operations Change Management dengan SOP Change Management masih memberikan hasil yang relevan walaupun pada beberapa poin memerlukan revisi.

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ABSTRAKPharmacists in the pharmaceutical industry has a professional responsibility to ensure that the quality of medicines produced meets the requirements and intended use by referring to the principles of Good Manufacturing Practice (GMP).Professional Pharmacist Internship is intended to provide practical experience and a real description of the role,duties and responsibilities of the pharmacist profession in the pharmaceutical industry.The internship was conducted at PT. AstraZeneca Indonesia for two months at quality assurance unit with the main activities were material induction from various departments,accomplising Annual Product Review (APR),accomplising Corrective Action Preventive Action (CAPA) and evidence based on self-inspection and accomplising procedures gap analysis.The induction which was given is about description of the tasks and functions of each departemen.The APR were two packing product APR of product I MY, I TW and I AU and also one repacking product APR of Z and B.As a result, both of packing and repacking products were released.Application of CAPA and evidence based on self-inspection documentation error were done by giving the SOP to the department who have unlisted previously.Wherease gap analysis of guidline the Robustness analysis and Process Trending with SOP Product Review Report and Standart Change Control in the Quality and also Compliance Operations Area and SOP Change Management with Change Management SOP still deliver a relevant results even if at some point require revision."

"ABSTRAKKesehatan merupakan hak dasar bagi setiap manusia, sehingga setiap negara perlu mengembangkan hak asasi manusia tersebut. Apoteker sebagai salah satu tenaga kesehatan wajib mengabdikan dirinya baik di industri farmasi maupun apotek. Dalam peningkatan pemahaman mengenai peran apoteker, maka dilakukan praktik kerja profesi apoteker di PT.Pfizer Indonesia dan Apotek Atrika. Metode yang digunakan dalam pembuatan tugas khusus ini adalah melalui studi literatur menggunakan CPOB 2018 untuk industri farmasi dan data pada website BPJS, websitePTSP di wilayah Depok, website e-katalog LKPP, serta peraturan perundang-undangan untuk apotek. Pada pelaksanaan praktik di industri farmasi, penulis melakukan annual product review terhadap Produk X yang merupakan salah satu produk unggulan dari PT.Pfizer Indonesia. Berdasarkan hasil pengkajian, Produk X telah sesuai dengan spesifikasi yang ditentukan dan seluruh hasil pengkajian Produk X periode 2019 akan dijadikan bahan evaluasi untuk meminimalkan terjadinya penyimpangan dan meningkatkan efisiensi Produk X di tahun selanjutnya. Untuk pelaksanaan praktik di apotek, penulis melakukan pembuatan rancangan apotek yang melayani Program Rujuk Balik (PRB) dan bekerjasama dengan BPJS di Kota Depok mulai dari penentuan lokasi, bangunan, jumlah karyawan hingga analisis keuangan. Berdasarkan analisa dari segala aspek, rancangan apotek yang dibuat telah layak untuk dibangun dan beroperasional dengan modal yang telah ditentukan.

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ABSTRACTHealth is a basic right for every human being, so that every country needs to develop these human rights. Pharmacists as one of the health workers are required to devote themselves in the pharmaceutical industry, the pharmacy, or both. To increasing understanding the role of pharmacists, the pharmacist student conduct to work practice. The authors work practice pharmacist profession at PT.Pfizer Indonesia and Apotek Atrika. In this study, the method which used is a study literature using CPOB 2018 for the pharmaceutical industry and data on the BPJS website, the PTSP website in the Depok area, the LKPP e-catalog website, and laws and regulations for pharmacies for the pharmacy. Implementation of practice in the pharmaceutical industry, the authors conducted an annual product review of Product X, which is one of the superior products of PT.Pfizer Indonesia. Based on the results of the assessment, Product X is in appropiate with the specified specifications and all the results of the assessment of Product X for the 2019 period will be used as evaluation to minimize the deviations and increase the efficiency of Product X in the next year. For the implementation of practice in pharmacies, the authors made a design for a pharmacy that serves the Referral Program and collaborates with BPJS in Depok City, starting from determining the location, building, number of employees until financial analysis. Based on an analysis of all aspects, the pharmacy design that was made was feasible to be built and operated with the specified capital."