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"Kualifikasi kinerja bertujuan untuk memverifikasi bahwa fasilitas, sistem dan peralatan yang telah terpasang dan difungsikan, bekerja secara efektif serta memberikan hasil yang konsisten. Dalam aktivitasnya, industri farmasi wajib menerapkan program kontrol, kualifikasi, dan validasi pada setiap aspek yang dapat berpengaruh terhadap kegiatan produksi dan mutu obat yang dihasilkan termasuk pada sarana penunjang kritis. Adapun salah satu sarana penunjang kritis di industri farmasi yaitu Sistem Tata Udara (HVAC). Laporan ini berisi tentang metode kualifikasi kinerja sistem HVAC terhadap parameter kritis yang dapat mempengaruhi kualitas produk selama proses produksi di Ruang Produksi Steril Non-Cephalosporin PT. Mahakam Beta Farma.

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Performance qualification aims to verify that facilities, systems and equipment that have been installed and functioned, work effectively and provide consistent results. In its activities, the pharmaceutical industry is required to implement control, qualification and validation programs in every aspect that can affect production activities and the quality of drugs produced, including critical supporting facilities. One of the critical supporting facilities in the pharmaceutical industry is the Air Conditioning System (HVAC). This report contains the method of performance qualification of the HVAC system for critical parameters that can affect product quality during the production process in the Non-Cephalosporin Sterile Production Room of PT Mahakam Beta Farma."

"Sistem tata udara memiliki peran penting dalam industri farmasi untuk memberikan perlindungan terhadap lingkungan pembuatan produk, memastikan produksi obat yang bermutu serta memberikan lingkungan kerja yang nyaman bagi personil. Tujuan penyusunan tugas khusus selama Praktek Kerja Profesi Apoteker di PT Mahakam Beta Farma yakni untuk menganalisis kesesuaian parameter kualifikasi kinerja sistem HVAC di area ruang produksi steril NonCephalosphorin sesuai peraturan CPOB. Penyusunan tugas khusus ini menggunakan metode dengan mengunggakan data performance qualification sistem heating, ventilation, and air conditioning ruang produksi steril NonCephalosporin periode 2022, selanjutnya di lakukan kesimpulan analisis sesuai spesifikasi dan kualifikasi perusahaan PT. Mahakam Beta Farma. Sehingga didapatkan kesimpulan bahwa proses kualifikasi PQ HVAC yang telah dilakukan, dapat disimpulkan bahwa ruang produksi steril NonCephalosporin memenuhi persyaratan spesifikasi dan kualifikasi yang telah ditetapkan oleh departemen Quality Assurance PT. Mahakam Beta Farma.

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Air conditioning systems have an important role in the pharmaceutical industry to protect the product manufacturing environment, ensure the production of quality drugs and provide a comfortable working environment for personnel. The purpose of preparing special assignments during the Pharmacist Professional Work Practice at PT Mahakam Beta Farma is to analyze the suitability of the HVAC system performance qualification parameters in the non-Cephalosphorin sterile production room area according to GMP regulations. The preparation of this special task uses a method by leaving data on performance qualification systems for heating, ventilation, and air conditioning in the non-Cephalosporin sterile production room for the 2022 period. Mahakam Beta Farma. So it can be concluded that the PQ HVAC qualification process that has been carried out, it can be concluded that the NonCephalosporin sterile production room meets the specification and qualification requirements set by the Quality Assurance department of PT. Mahakam Beta Farma."

"Apoteker memiliki peran penting dalam pekerjaan kefarmasian. Salah satu hal penting yang perlu dilakukan untuk menjadi seorang apoteker profesional adalah berpartisipasi langsung dalam bidang praktik kefarmasian. Oleh karena itu, calon apoteker dituntut untuk menjalani praktik profesi sebagai bekal untuk memahami peran apoteker, serta meningkatkan kemampuan sebelum memasuki dunia kerja. Praktik Kerja Profesi Apoteker dilaksanakan di Apotek Kimia Farma periode Februari 2022 dan PT Mahakam Beta Farma periode Maret - April 2022. Melalui proses PKPA di apotek dan industri farmasi tersebut, calon apoteker diharapkan mampu memperoleh pengalaman, pengetahuan, wawasan, dan keterampilan yang sesuai untuk melakukan pekerjaan kefarmasian.

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The pharmacists have important role in pharmacy practice. One of important things that must be done to become a professional pharmacist is participate directly in the field of pharmacy practice. Therefore, prospective pharmacists are required to undergo professional practice as a provision and experience to understand the role of pharmacists, and improve their abilities before entering the world of work. The Professional Practice of Pharmacist is held at Apotek Kimia Farma period February 2022 and PT Mahakam Beta Farma period March – April 2022. Through the activities in the pharmacy and pharmaceutical industry, prospective pharmacists are expected to be able to get appropriate experience, knowledge, insight, and skills to perform pharmaceutical practice."