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"Produk injeksi steril membutuhkan kebersihan dan sterilisasi yang tinggi agar keamanan dan efektivitas produk yang dihasilkan juga terjamin dengan tetap memenuhi standar Good Manufacturing Practice (GMP). Proses pembersihan peralatan produksi dapat dilakukan dengan metode cleaning in place (CIP) dan sterilization in place (SIP) yang penerapannya tanpa harus melepas ataupun memindahkan peralatan produksi. Pada proses akhir pembersihan tangki mixing, yaitu pengeringan, PT CKD OTTO Pharmaceuticals menggunakan gas nitrogen sebagai pengering yang membutuhkan biaya lebih tinggi karena penyimpanan gas nitrogen sendiri harus dalam tekanan tinggi, menggunakan tangki khusus. Clean air sterile dapat dipertimbangkan untuk digunakan sebagai pengganti gas nitrogen karena lebih cost effective, lebih aman untuk personil dan lingkungan. Dari hasil pengkajian terkait penggantian gas nitrogen menjadi clean air sterile untuk proses pengeringan pada proses Cleaning in Place (CIP) – Sterilization in Place (SIP) didapatkan bahwa penggantian gas nitrogen menjadi clean air sterile dapat dilakukan dengan penambahan selang penghubung antara selang compressed air dengan selang nitrogen, beserta penambahan katup pada masing-masing selang penghubung dan selang nitrogen; penggantian gas ini juga relatif aman dalam pembersihan dan sterilisasi permukaan interior tangki mixing, serta seluruh risiko yang mungkin terjadi dapat dikendalikan oleh sistem yang ada; serta dapat dilakukan penggantian apabila memenuhi parameter dari uji keberterimaan, yaitu memenuhi uji inspeksi visual setelah proses CIP-SIP.

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Sterile injection products require high cleanliness and sterilization to ensure the safety and effectiveness of the resulting products while maintaining Good Manufacturing Practice (GMP) standards. The cleaning of production equipment can be achieved using the cleaning in place (CIP) and sterilization in place (SIP) methods, which can be applied without the need to disassemble or relocate the production equipment. In the final stage of cleaning the mixing tank, which is drying, PT CKD OTTO Pharmaceuticals employs nitrogen gas as a drying agent, incurring higher costs due to the need for high-pressure nitrogen gas storage in specialized tanks. The consideration of using clean sterile air as a replacement for nitrogen gas is deemed more cost-effective and safer for personnel and the environment. The assessment regarding the replacement of nitrogen gas with clean sterile air for the drying process in the Cleaning in Place (CIP) – Sterilization in Place (SIP) process revealed that this replacement can be achieved by adding a connecting hose between the compressed air and nitrogen hoses, along with the addition of valves to each connecting hose and the nitrogen hose. This gas replacement method is also relatively safe for cleaning and sterilizing the interior surfaces of the mixing tank, and any potential risks can be controlled by the existing system. Additionally, the replacement can proceed if it meets the acceptance criteria parameters, including passing a visual inspection after the CIP-SIP process.

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"Kanker menjadi salah satu penyebab kematian utama pada 10 juta kasus di seluruh dunia pada tahun 2020. Salah satu terapi yang dapat diberikan kepada pasien kanker yaitu menggunakan obat sitostatika. Proses produksi obat sitostatika menurut CPOB memerlukan penanganan khusus seperti produksi di gedung terpisah dari produk non sitostatika, area produksi yang dedikatif, pengaturan sistem tata udara, dan pengaturan kelas kebersihan untuk proses produksi sediaan steril, serta perlindungan terhadap personel dan produk. Penelitian ini bertujuan untuk menelaah proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals, menganalisis kesesuaian proses produksi sediaan sitostatika dengan CPOB dan menganalisis perbedaan proses produksi sediaan sitostatika dibandingkan proses produksi sediaan steril lainnya. Pengambilan data dilakukan dengan observasi, wawancara, dan studi literatur. Hasil penelitian menunjukkan proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals meliputi tahapan  penerimaan bahan awal dan bahan kemas, sampling bahan awal dan bahan kemas, penyiapan sebelum produksi, sterilisasi, pencucian vial dan depyrogenation, penimbangan material, mixing, transfer produk, filling, freeze drying, crimping, external washer, inspeksi visual, pelabelan, pengemasan sekunder, hingga proses agregasi. Seluruh proses produksi sediaan sitostatika di PT CKD OTTO Pharmaceuticals telah sesuai dengan CPOB meliputi aspek bangunan-fasilitas, personalia, kelas kebersihan yang digunakan, pengaturan tekanan udara, sistem terkait produksi, hingga monitoring lingkungan. Terakhir, perbedaan proses produksi sediaan sitostatika dibandingkan proses produksi sediaan steril lainnya terletak pada bangunan, tekanan udara yang digunakan, tahapan penerimaan bahan awal, penimbangan material, mixing, filing, dan external washer.

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Cancer is one of the leading causes of death in 10 million cases worldwide in 2020. One of the therapies that can be given to cancer patients is using cytostatic drugs. The production process of cytostatics according to CPOB requires special handling such as production in a separate building from non-cytostatics products, dedicative production areas, air system settings, and hygiene class settings for the production process of sterile preparations, as well as protection of personnel and products. This study aims to examine the production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals, analyze the suitability of the production process of cytostatics preparations with CPOB and analyze the differences in the production process of cytostatics preparations compared to the production process of other sterile preparations. Data collection was carried out by observation, interview, and literature study. The results showed that the production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals included the stages of receiving initial materials and packaging materials, sampling initial materials and packaging materials, pre-production preparation, sterilization, vial washing and depyrogenation, material weighing, mixing, product transfer, filling, freeze drying, crimping, external washer, visual inspection, labeling, secondary packaging, to the aggregation process. The entire production process of cytostatics preparations at PT CKD OTTO Pharmaceuticals is in accordance with CPOB, including aspects of building-facilities, personnel, hygiene classes used, air pressure settings, production-related systems, and environmental monitoring. Finally, the difference in the production process of cytostatics preparations compared to the production process of other sterile preparations lies in the building, the air pressure used, the stages of receiving initial materials, weighing materials, mixing, filing, and external washers."

"Dalam pelaksanaan prosedur sterilisasi di RSUP Sanglah Denpasar masih ditemukan ada beberapa indikator sterilisasi yang belum sesuai target diantaranya janji hasil pelyanan sterilisasi untuk kamar operasi IRD masih di bawah 100 % dan kesalahan distribusi masih diatas 5 kejadian per bulan. Penelitian ini bertujuan mengetahui faktor-faktor yang berubungan dengan kepatuhan petugas terhadap prosedur sterilisasi instrument bedah endo urologi di Instalasi Sterilisasi Sentral (ISS). Sample sebanyak 33 orang dari seluruh petugas yang bekerja di ISS. Hasil penelitian ini menemukan adanya hubungan antara faktor masa kerja, pengawasan, sarana dan pelatihan dengan kepatuhan petugas dalam pelaksanaan sterilisasi instrument bedah endo urologi. Kepatuhan yang paling rendah ditemukan pada prosedur penerimaan : memisahkan alat kotor, pencucian: melakukan penyikatan, validasi : uji fungsi alat, pengemasan : melakukan kebersihan tangan, sterilisasi : tidak menumpuk alat, penyimpanan : menempetkan alat, distribusi : desinfeksi troly, dan faktor yang paling dominan adalah sarana kerja. Disarankan untuk memberikan pelatihan berkala dan penambahan fasilitas pencucian.

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In implementing sterilization procedure in Sanglah Hospital, Denpasar, some sterilizationindicators are still below the target such as the minimum required time less then 100% and distribution error above 5 events per month. The aim of this study was to identify factorsrelated to staff compliance in sterilization procedure of surgical instruments in endo-urology of the Central Sterilisation Installation (CSI). The sample of this study consisted of 33 CSI staff. Findings indicated a significant correlation between the length of service, supervision, resources and training with staff compliance in conducting sterilization for endo-urology surgery. The lowest compliance was found in the admission procedure: separating dirty equipment, washing: brushing, validation: testing tool function, packing: washing hand, sterilization: not accumulating equipment, storage: placing equipment, and distribution: trolley disinfection. In addition, the most dominant factor is resources. It is recommended to provide training for staff, increase facilities for washing and disinfection."

"Perkembangan teknologi khususnya software pada bidang farmasi industri dapat meningkatkan efisiensi perhitungan dan olah data hasil pengujian. PT. CKD OTTO Pharmaceuticals melakukan pergantian software perhitungan pada hasil pengujian di bagian Quality Control (QC), khususnya laboratorium, dari Microsoft Excel ke Custom Field (Empower dan Control Panel OpenLAB). Pergantian software dilakukan dengan harapan dapat meminimalisir adanya human error karena transfer data secara manual. Adanya pergantian software perlu dilakukan verifikasi software untuk melihat konsistensi dan kebenaran hasil akhir yang diperoleh. Penelitian ini dilakukan untuk melakukan verifikasi Custom Field (Empower dan Control Panel OpenLAB) sebagai software perhitungan yang baru untuk memastikan akurasi hasil perhitungan. Data yang akan diverifikasi diperoleh dari batch record produk B, D dan P secara retrospektif kemudian dilakukan verifikasi secara prospektif. Hasil verifikasi perhitungan menggunakan Custom Field (Empower dan Control Panel OpenLAB) untuk produk B, D dan P yang diperoleh menunjukkan kesesuaian hasil terhadap hasil perhitungan dari Excel. Verifikasi yang telah berhasil dilakukan yaitu untuk perhitunan pengujian kadar, impurity, kandungan etanol dan sisa pelarut produk B, D, dan P di PT. CKD OTTO Pharmaceuticals.

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The development of technology, especially software in the pharmaceutical industry, can improve the efficiency of calculation and data processing from test results. PT. CKD OTTO Pharmaceuticals has replaced the calculation software for test results in the Quality Control (QC) department, particularly in the laboratory, from Microsoft Excel to Custom Field (Empower and Control Panel OpenLAB). This software change aims to minimize human errors that may occur during manual data transfer. Verification of the software change is necessary to ensure consistency and accuracy of the final results obtained. This study verifies Custom Field (Empower and Control Panel OpenLAB) as the new calculation software to ensure the accuracy of calculation results. Data for verification were obtained retrospectively from batch records of products B, D, and P, followed by prospective verification. The verification results using Custom Field (Empower and Control Panel OpenLAB) for products B, D, and P showed conformity with the calculation results obtained from Excel. Successful verification was conducted for the calculation of assay, impurity, ethanol content, and residual solvents of products B, D, and P at PT. CKD OTTO Pharmaceuticals."

"Industri farmasi dan apotek merupakan tempat dilaksanakannya praktik kefarmasian. Dalam melaksanakan praktik kefarmasian, apoteker sebagai orang yang berwenang harus mempunyai keahlian dalam penerapan CPOB di industri farmasi maupun penerapan standar pelayanan kefarmasian di apotek. Oleh karena itu, calon Apoteker perlu mendapatkan pengalaman praktik baik pada industri farmasi maupun apotek sebagai perbekalan untuk bekerja sebagai profesional. Hal ini menjadi dasar bagi Program Profesi Apoteker Universitas Indonesia untuk memberikan saya kesempatan untuk melaksanakan Praktik Kerja Profesi Apoteker (PKPA) pada PT. CKD OTTO Pharmaceuticals dan Apotek Roxy Biak. Selama melaksanakan PKPA, calon apoteker diharapkan dapat memahami mengenai peran, tugas, dan tanggung jawab apoteker di industri farmasi dan apotek sesuai dengan ketentuan CPOB maupun standar pelayanan kefarmasian di apotek.

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Pharmaceutical industry and pharmacies are places where pharmaceutical practices are carried out. In carrying out pharmaceutical practices, pharmacists as authorized persons must have expertise in the application of CPOB in the pharmaceutical industry and the application of pharmaceutical care standards in pharmacies. Therefore, apothecary student need to gain practical experience in both the pharmaceutical industry and pharmacies to work as professionals. Therefore Apothecary Professional Programme University of Indonesia has given me the opportunity to carry out the Praktik Kerja Profesi Apoteker (PKPA) at PT. CKD OTTO Pharmaceuticals and Apotek Roxy Biak. During the implementation of PKPA, apothecary student are expected to understand the roles, duties, and responsibilities of pharmacists in the pharmaceutical industry and pharmacies in accordance with the provisions of CPOB and pharmaceutical service standards in pharmacies."

"Salah satu sarana penunjang kritis yang ada di PT CKD OTTO Pharmaceuticals yaitu Sistem Pengolahan Air (SPA). Perlu dilakukan suatu upaya untuk menjaga kualitas air agar dapat dikendalikan mutunya sesuai spesifikasi dan menjamin produk farmasi yang dihasilkan aman, berkhasiat, dan bermutu. Salah satu upaya yang dapat dilakukan yaitu dengan pemantauan terhadap sumber air, peralatan pengolahan air, dan air hasil pengolahan di industri farmasi, baik terhadap kontaminasi kimiawi, biologis, dan bila perlu terhadap cemaran endotoksin. Oleh karena itu, dalam tugas khusus ini akan dibahas mengenai hasil tren dari data pemantauan air periode bulan Juli 2023 - September 2023 di PT CKD OTTO Pharmaceuticals. Penelitian ini bertujuan untuk memantau hasil analisis tren untuk melihat apakah ada data yang berada di luar spesifikasi dan melebihi alert level. Pengumpulan data dilakukan secara retrospektif dari analytical report yang diperoleh dari departemen Quality Control. Data selanjutnya dianalisis dan diinterpretasikan menggunakan tabel dan grafik sehingga dapat diamati tren data pemantauan air periode bulan Juli 2023 - September 2023 di PT CKD OTTO Pharmaceuticals dan membandingkan tren data pemantauan air periode sebelumnya (April 2023 - Juni 2023). Hasil menunjukkan bahwa semua hasil pengujian di beberapa titik sampling masih sesuai dengan tren data periode sebelumnya sehingga tidak terdapat data yang berada di luar spesifikasi atau melebihi alert limit. Pemantauan air yang dilakukan setiap 3 bulanan ini dilakukan sebagai immediate action untuk mengantisipasi tren data yang buruk pada waktu yang akan datang.

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One of the critical supporting facilities at PT CKD OTTO Pharmaceuticals is the Water Treatment System (SPA). Efforts need to be made to maintain water quality so that the quality can be controlled according to specifications and ensure that the pharmaceutical products produced are safe, efficacious and of high quality. One effort that can be made is by monitoring water sources, water processing equipment, and water resulting from processing in the pharmaceutical industry, both for chemical and biological contamination, and if necessary for endotoxin contamination. Therefore, in this special assignment we will discuss the trend results from water monitoring data for the period July 2023 - September 2023 at PT CKD OTTO Pharmaceuticals.

This research aims to monitor the results of trend analysis to see whether there is data that is outside specifications and exceeds the alert level. Data collection was carried out retrospectively from analytical reports obtained from the Quality Control department. The data is then analyzed and interpreted using tables and graphs so that trends in water monitoring data for the period July 2023 - September 2023 at PT CKD OTTO Pharmaceuticals can be observed and compared with trends in water monitoring data for the previous period (April 2023 - June 2023).

The results show that all test results at several sampling points are still in accordance with the data trend for the previous period so that there is no data that is outside specifications or exceeds the alert limit. Water monitoring, which is carried out every 3 months, is carried out as an immediate action to anticipate bad data trends in the future."

"Manajemen kontainmen dimulai dari penentuan marker produk, kriteria penerimaan, penentuan lokasi sampling dan penentuan metode sampling. Manajemen kontainmen perlu dilakukan setelah kegiatan produksi dilakukan. Manajemen kontainmen berlaku untuk fasilitas penanganan produk farmasi (termasuk zat aktif) yang mengandung zat berbahaya. PT. CKD OTTO Pharmaceutical telah menerapkan Manajemen kontainmen sejak 2018, dan SOP Manajemen Kontainmen yang telah diperbaharui pada kegiatan PKPA diantaranya melakukan pembaruan struktur organisasi, lokasi pengambilan sampel, kriteria penerimaan, dan frekuensi kegiatan manajemen kontainmen. Hasil dari pelaksanaan manajemen kontainmen PT. CKD OTTO Pharmaceutical yang dilakukan di pada area-area lokasi pengambilan sampel yaitu tidak ditemukan marker produk pada area-area tersebut dan dapat dikatakan memenuhi kriteria penerimaan.

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Containment management starts from determining product markers, acceptance criteria, determining sampling locations and determining sampling methods. Containment management needs to be carried out after production activities are carried out. Containment management applies to facilities handling pharmaceutical products (including active substances) containing hazardous substances. PT. CKD OTTO Pharmaceutical has implemented containment management since 2018, and the updated Containment Management SOPs for PKPA activities include updating the organizational structure, sampling locations, acceptance criteria, and frequency of containment management activities. The results of the implementation of PT. OTTO Pharmaceutical CKD was carried out in the areas where the samples were taken, meaning no product markers were found in these areas and can be said to have met the acceptance criteria."

"Continued Process Verification (CPV) adalah pengumpulan dan analisis data terkait produk dan proses yang berhubungan dengan kualitas produk yang bertujuan untuk menunjukkan pemeliharaan kontrol selama siklus hidup yang memenuhi syarat. PT CKD OTTO Pharmaceuticals selaku Industri Farmasi yang berspesialisasi pada pengobatan onkologi juga menerapkan Continued Process Verification (CPV) yang dilakukan terhadap dua produk obat yakni produk X dan Y. Aktualisasi alur pelaksanaan Continued Process Verification (CPV) yang dilakukan terhadap produk X dan Y yang diproduksi oleh PT CKD OTTO Pharmaceuticals dimulai dari Quality Risk Assessment (QRA) Continued Process Verification (CPV), pembuatan protokol Continued Process Verification (CPV), pengumpulan dan analisis data, serta evaluasi dan pembuatan laporan Continued Process Verification (CPV). Analisis data dilakukan menggunakan metode Statistical Process Control (SPC), meliputi bagan kontrol dan analisis kapabilitas proses. Analisis kemampuan proses yang dihitung dalam pelaksanaan Continued Process Verification (CPV) antara lain Process Performance (Pp) dan Process Performing Index (Ppk). Hasil dari analisis data yang dilakukan menunjukkan bahwa nilai Pp yang diperoleh lebih dari 1,00 yang berarti memenuhi syarat. Namun, pada beberapa parameter, seperti suhu sterilisasi, pH mixing, particulate matter ≤ 25μm, serta related substance 10-deacetylpaclitaxel, 7-epipaclitaxel, total impurities, dan bioburden diperoleh nilai Ppk kurang dari 1,00 atau tidak memenuhi syarat dikarenakan analisis yang dilakukan masih menggunakan Capability Process Sixpack dengan mengasumsikan bahwa data terdistribusi normal (belum dilakukan analisis data menggunakan pola distribusi yang sesuai untuk masing-masing parameter).

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Continued Process Verification (CPV) is the collection and analysis of product and process data related to product quality that aims to demonstrate the maintenance of controls throughout the qualified life cycle. PT CKD OTTO Pharmaceuticals as a Pharmaceutical Industry which specializes in oncology treatment also implements Continued Process Verification (CPV) which is carried out on two medicinal products namely products X and Y. Actualization of the flow of implementation of Continued Process Verification (CPV) which is carried out on products by PT CKD OTTO Pharmaceuticals starting from Quality Risk Assessment (QRA) Continued Process Verification (CPV), creating a Continued Process Verification (CPV) protocol, collecting and analyzing data, as well as evaluating and creating a Continued Process Verification (CPV) report. Data analysis was carried out using the Statistical Process Control (SPC) method, including control charts and process capability analysis. Analysis of process capabilities calculated in the implementation of Continued Process Verification (CPV) includes Process Performance (Pp) and Process Performing Index (Ppk). The results of the data analysis carried out show that the Pp value obtained is more than 1.00, which means it meets the requirements. However, for several parameters, such as sterilization temperature, pH mixing, particulate matter ≤ 25μm, as well as related substances 10-deacetylpaclitaxel, 7-epipaclitaxel, total impurities, and bioburden, the Ppk value was less than 1.00 or did not meet the requirements due to the analysis carried out. still using Capability Process Sixpack assuming that the data is normally distributed (data analysis has not been carried out using appropriate distribution patterns for each parameter)."

"Praktek kerja profesi di PT CKD-OTTO Pharmaceuticals Periode Januari – Februari Tahun 2018 bertujuan untuk mengerti peranan, tuga dan tanggung jawab apoteker di Industri Farmas, 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 “Kualifikasi Operasional Biological Safety Cabinet Kelas II Tipe A2 di PT CKD-OTTO Pharmaceuticals”. Tujuan dari pelaksanaan tugas khusus di PT CKD-OTTO Pharmaceuticals adalah mengkaji hasil kualifikasi operasional Biological Safety Cabinet Kelas II Tipe A2 yang dilakukan di PT CKD-OTTO Pharmaceuticals. Secara umum, PT CKD-OTTO Pharmaceuticals masih berada dalam tahap pemenuhan 12 aspek CPOB dengan baik dan benar, penulis juga telah memahami peran, tugas, wawasan dan tanggung jawab apoteker di industri farmasi

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Internship at PT CKD-OTTO Pharmaceuticals Period January - February 2018 aims to understand the role, duties and responsibilities of pharmacists in the pharmaceutical industry and to understand 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 “Operational Quallification of Biological Safety Cabinet Class II Type 2A at PT CKD-OTTO Pharmaceuticals”. The purpose of this special assignment is to review the results of operational qualification of Biological Safety Cabinet Class II Type A2 conducted at PT CKD-OTTO Pharmaceuticals. In general, PT CKD-OTTO Pharmaceuticals is still int the stage of fulfilling 12 aspect GMP, 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"

"Profesi apoteker merupakan salah satu bagian dari tim pelayanan kesehatan yang memiliki peran penting dalam bidang industri farmasi, rumah sakit, pelayanan, dan pemerintahan. Salah satu hal penting yang harus dilakukan agar dapat menjadi seorang apoteker profesional adalah berpartisipasi langsung dalam melakukan praktik kefarmasian. Maka dari itu, seorang calon apoteker harus melakukan Praktik Kerja Profesi Apoteker untuk menjadi apoteker yang profesional sebagai bekal agar memahami peran apoteker dan mendapatkan pengalaman yang diperlukan untuk memasuki dunia pekerjaan. Praktik Kerja Profesi Apoteker (PKPA) kali ini dilaksanakan di PT. CKD OTTO Pharmaceuticals periode Januari – Februari 2022, Apotek Roxy Jakasampurna periode April 2022. Dengan dilaksanakannya Praktik Kerja Profesi Apoteker (PKPA) di industri farmasi dan apotek, calon apoteker diharapakan untuk bisa menambah wawasan, pengalaman, pengetahuan, keterampilan dan gambaran mengenai pekerjaan yang akan dilakukan oleh seorang apoteker sehingga dapat menunjang untuk melakukan pekerjaan kefarmasian nantinya.

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The pharmacist profession is one part of the health care team that has an important role in the pharmaceutical industry, hospitals, services, and government. One of the important things that must be done in order to become a professional pharmacist is to participate directly in the practice of pharmacy. Therefore, a prospective pharmacist are required to carry out the Pharmacist Professional Practice to become a professional pharmacist as a provision to understand the role of pharmacists and gain the necessary experience to enter the world of work. This time the Praktik Kerja Profesi Apoteker (PKPA) was held at PT. CKD OTTO Pharmaceuticals for the period January – February 2022, Apotek Roxy Jakasampurna for the period April 2022. With the implementation of the Praktik Kerja Profesi Apoteker (PKPA) in the pharmaceutical and pharmacy industry, prospective pharmacists are expected to be able to obtain insights, experiences, knowledges, skills and an overview of the work that will be done by a pharmacist so that it can support to do pharmaceutical practice later."