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"ABSTRAKPraktik kerja profesi di PT Finusolprima Farma Internasional Periode Bulan Januari ndash; Februari 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 ldquo;Gap Analysis Matrix Regulasi PIC/S 2017, CPOB 2012, WHO TRS, dan EU GMP Guidelines dan Gap Analysis pada Departemen QA PT Finusolprima Farma Internasional rdquo;. Tujuan dari pelaksanaan tugas khusus di PT Finusolprima Farma Internasional adalah agar calon apoteker mampu membuat matriks gap analysis berdasarkan pedoman GMP PIC/S 2017, CPOB 2012, WHO TRS, dan EU GMP Guidelines dan melakukan gap analysis pada Departemen QA PT Finusolprima Farma Internasional.

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ABSTRACTInternship at PT Finusolprima Farma Internasional Plant Period January - February 2018 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 prospective pharmacist can also have insight, knowledge, skills and practical experience to undertake pharmaceutical practices in the pharmaceutical industry. The special assignment given is ldquo;Gap Analysis Matrix of PIC/S 2017 GMP Guidelines, CPOB 2012, WHO TRS, dan EU GMP Guidelines and Gap Analysis of Quality Assurance Department of PT Finusolprima Farma Internasional rdquo;. The objective of this special assignment is so that prospective pharmacist is able to create gap analysis matrix based on PIC/S 2017, CPOB 2012, WHO TRS, dan EU GMP Guidelines and conduct a gap analysis in the QA Department of PT Finusolprima Farma Internasional. "

"Praktik kerja profesi di PT. Finusolprima Farma Internasional Periode Bulan Februari ndash; Maret Tahun 2018 bertujuan agar calon Apoteker memahami tugas dan tanggung jawab apoteker di industri farmasi, penerapan Cara Pembuatan Obat yang Baik CPOB di industri farmasi, serta memahami permasalahan dan strategi penyelesaian yang dihadapi di Industri Farmasi. Tugas khusus yang diberikan yaitu berjudul ldquo;Gap Analysis Antara Kondisi Aktual di PT. Finusolprima Farma Internasional terhadap Regulasi PIC/S, CPOB, TRS, dan EU Guidelines rdquo;. Tujuan dari pelaksanaan tugas khusus adalah memahami regulasi terkait pembuatan obat di berbagai negara dengan kondisi aktual yang terjadi di industri beserta pemenuhan nya terhadap regulasi tersebut. Secara umum, PTFinusolprima Farma Internasionaltelah menerapkan 12 aspek CPOB dengan baik dan benar.

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Internshipat PT. Finusolprima Farma International Period February - March 2018 aims to prospective Pharmacists understand the duties and responsibilities of pharmacists in the pharmaceutical industry, the implementation of Good Manufacturing Practices GMP in the pharmaceutical industry, and understand the problems and settlement strategies faced in the Pharmaceutical Industry. The special task given is entitled Gap Analysis Between Actual Conditions in PT. Finusolprima Farma International against Regulation of PIC/S, CPOB, TRS, and EU Guidelines . The purpose of the implementation of specific tasks is to understand the regulations related to the manufacture of drugs in various countries with the actual conditions occurring in the industry and its compliance with the regulation. In general, PT Finusolprima Farma International has applied 12 aspects of GMP well and correctly."

"Produk steril memiliki persyaratan minimal risiko kontaminasi mikroba, partikulat, dan endotoksin/pirogen pada fasilitas, peralatan, dan proses harus dirancang, dikualifikasi, dan divalidasi dengan tepat untuk meningkatkan perlindungan produk. Strategi pengendalian kontaminasi / Contamition Control Strategy (CCS) harus diterapkan di seluruh fasilitas industri farmasi untuk menilai efektivitas seluruh rancangan, prosedur, teknis, dan organisasional serta pemantauan yang telah digunakan untuk mengelola risiko terhadap mutu produk. Penyusunan Risk Assessment Terkait Control Contamination Strategy (CCS) di PT Finusolprima Farma International dilakukan dengan melakukan studi literatur pada Prosedur Tetap, membandingkan prosedur yang telah ada dengan ketentuan EU GMP & CPOB 2018 dan menyusun hasil penerapan CCS. Dengan adanya kegiatan Penyusunan Risk Assessment Terkait Control Contamination Strategy (CCS) di PT Finusolprima Farma International diketahui elah dilakukannya analisis efektivitas Contamination Control Strategy (CCS) menggunakan prinsip manajemen risiko mutu pada PT Finusolprima Farma International namun masih terdapat prosedur pengendalian kontaminasi yang belum terdokumentasi dengan baik sehingga perlu ditambahkan untuk memudahkan personil terkait dan pencegahan kontaminasi dapat lebih dikendalikan.

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Sterile products have minimal risk requirements for microbial, particulate and endotoxin/pyrogen contamination. Facilities, equipment and processes must be appropriately designed, qualified and validated to increase product protection. Contamination control strategies (CCS) must be implemented in all pharmaceutical industry facilities to assess the effectiveness of all designs, procedures, and technical and organizational monitoring used to manage product quality risks. Preparing a Risk Assessment Related to Control Contamination Strategy (CCS) at PT Finusolprima Farma International was carried out by conducting a literature study on Standing Procedures, comparing existing procedures with the provisions of EU GMP & CPOB 2018 and compiling the results of CCS implementation. With the activity of Preparing a Risk Assessment Related to Control Contamination Strategy (CCS) at PT Finusolprima Farma International, it is known that an analysis of the effectiveness of Contamination Control Strategy (CCS) has been carried out using quality risk management principles at PT Finusolprima Farma International. However, contamination control procedures still need to be properly documented. So, it needs to be added to make it easier for related personnel and contamination prevention to be better controlled."

"Praktik kerja profesi apoteker merupakan suatu praktik profesi dimana seorang calon apoteker berkesempatan untuk berpartisipasi langsung untuk melakukan praktik kefarmasian dalam berbagai sarana kefarmasian seperti industri farmasi dan apotek. Melalui praktik kerja profesi apoteker, apoteker dapat menambah wawasan, pengetahuan serta keterampilan dari berbagai sarana kefarmasian sebelum kemudian memasuki dunia kerja. Praktik kerja profesi apoteker dilaksanakan di PT Finusolprima Farma Internasional pada periode januari – Februari 2022 dan Apotek Roxy Poltangan pada periode Maret 2022.  Melalui berbagai pengalaman yang didapat dari praktik kerja profesi ini, calon apoteker  diharapkan mendapatkan bekal yang cukup baik dari pengetahuan, pengalaman dan keterampilan mengenai  peran apoteker diberbagai sarana kefarmasian.

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Pharmacist professional practice is a professional practice where a prospective pharmacist has the opportunity to participate and learn about professional pharmaceutical practice in various pharmaceutical facilities such as pharmaceutical industry and pharmacies. Through the pharmacist professional practice, prospective pharmacists can increase their knowledge about pharmacist role and skill from various pharmaceutical facilities. Pharmacist professional practice held at PT Finusolprima Farma International period january – February 2022 and Apotek Roxy Poltangan period March 2022.  Over the distinct experiences gained from pharmacist professional practice, prospective pharmacists are expected to get more in depth knowledge, experiences and skills regarding pharmacists role in various pharmaceutical facilities."