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"Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas, small molecules, large molecules, and medical devices, and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers. "

"This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries."

"This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years."

"Bagian produksi merupakan inti dari pembuatan obat yang melakukan proses produksi dari bahan hingga menjadi produk jadi. Salah satu penunjang dalam berlangsungnya proses produksi adalah tersedianya gudang atau tempat penyimpanan. Tujuan penerapan prinsip 3R (Ringkas, Rapi, dan Resik) adalah untuk mengoptimalkan produktivitas di dalam gudang. Penerapan prinsip ringkas, rapi, dan resik dilakukan dengan cara dikaji dan diobservasi terlebih dahulu kemudian baru dibuat rencana tindak lanjut dan penerapannya. Gudang peralatan dan perlengkapan departemen produksi menjadi lebih terorganisir setelah penerapan prinsip ringkas, rapi, dan resik sehingga diharapkan produktivitas di dalam gudang menjadi lebih optimal.

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The production part is the core of medicine manufacturing which carries out the production process from ingredients to finished products. One of the supports in the production process is the availability of a warehouse or storage place. The purpose of applying the 3S principle (Sort, Set in Order, and Shine) is to optimize productivity in the warehouse. The application of the principles of sort, set in order, and shine is carried out by studying and observing first and then making a follow-up plan and its implementation. The equipment and supplies warehouse of the production department becomes more organized after the application of the principles of sort, set in order, and shine, so that it is expected that productivity in the warehouse will be more optimal."

"Industri alat kesehatan di Indonesia memiliki potensi yang menjanjikan dengan perkembangannya yang meningkat cepat. Pertumbuhan produsen dan distributor pada industri ini menunjukkan bahwa persaingan semakin kompetitif sehingga mendorong perusahaan di dalamnya untuk bekerja lebih efektif. PT. XYZ merupakan salah satu perusahaan distributor alat kesehatan di Indonesia. Saat ini, terdapat beberapa risiko di dalam rantai pasok gudang sentral PT. XYZ. Oleh karena itu, diperlukan sebuah manajemen risiko rantai pasok menyeluruh dalam gudang sentral PT. XYZ sebagai tindak pencegahan. Penelitian ini memiliki tujuan untuk mengidentifikasi agen risiko prioritas pada gudang sentral PT. XYZ serta menentukan rekomendasi mitigasi risiko prioritas untuk mengatasinya. Metode yang digunakan adalah House of Risk (HOR) yang terdiri dari dua fase. HOR fase 1 bertujuan untuk menentukan agen risiko prioritas dan HOR fase 2 untuk memilih aksi mitigasi prioritas. Hasil penelitian menunjukkan bahwa terdapat 11 agen risiko prioritas pada gudang sentral PT. XYZ berdasarkan nilai aggregate risk potential (ARP) tertinggi dengan 9 aksi mitigasi prioritas berdasarkan nilai effectiveness to difficulty ratio (ETD) yang direkomendasikan agar diimplementasikan terlebih dahulu oleh perusahaan.

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The medical device industry in Indonesia possesses promising potential with rapid development in recent years. The growth of manufacturers and distributors within this industry indicates increasing competition, meaning companies are demanded to operate more efficiently. PT. XYZ is one of the medical device distributors in Indonesia. Currently there are several risks associated with the supply chain of PT. XYZ’s central warehouse. Therefore, a comprehensive supply chain risk management within the central warehouse of PT. XYZ is needed as a preventive measure. This study aims to identify the priority risk agents in the central warehouse of PT. XYZ and determine the priority risk mitigation recommendations to address these risks. This study uses House of Risk method which consists of two phases. HOR phase 1 aims to identify the priority risk agents and HOR phase 2 focuses on selecting the priority mitigation actions. The results of the study show that there are 11 priority risk agents in PT. XYZ’s central warehouse based on the highest aggregate risk potential (ARP) values with 9 priority mitigation actions recommended based on the effectiveness to difficulty ratio (ETD) to be implemented by the company first."

"Manajemen peralatan laboratorium merupakan bagian dari manajemen sumber daya puskesmas tetapi belum mengimplemetasikan sistem manajemen peralatan medis dengan baik dan masih terdapat beberapa kekurangan dalam elemen penilaian Permenkes No.46 tahun 2015. Riset ini bertujuan untuk melakukan penilaian pelaksanaan manajemen peralatan laboratorium puskesmas di Kota Kendari dengan metode deskriptif eksplanatif, dimulai dengan merancang kuesioner, menyajikan data kemudian dianalisis dengan uji korelasi untuk melihat hubungan antara variabel. Hasil riset ini menyimpulkan : 1 terdapat 6 puskesmas sudah memenuhi standar Permenkes No.46 tahun 2015; 2 15 puskesmas belum memenuhi standar teori HTM, dan 3 terdapat korelasi antara kegiatan pemeliharaan r=0,898 , perencanaan r=0,896 , recall r=0,883 , uji coba alat r=0,875 , evaluasi r=0,849 dan SDM r=0,800 pada proses manajemen peralatan laboratorium.

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Management of laboratory equipment is part of the resource management of public health center but it has not implemented the medical equipment management system properly and there are still some deficiencies in the assessment element of Health Department Law No.46 Year 2015. This research aims to evaluate the implementation of laboratory equipment of public health center management of in Kendari City with explanative descriptive method, starting with designing questionnaires, presenting data and being analyzed by correlation test to see the relation between variables. The results of this research conclude 1 there are 6 of public health center already met the standard of Health Department Law No.46 year 2015 2 there are 15 of public helath center have not met the standard of HTM theory, and 3 there is correlation between maintenance activity r 0,898 , program r 0,896 , recall r 0,883 , instrument test r 0,875 , evaluation r 0,849 and human resource r 0,800 on laboratory equipment management process."

"Penelitian ini membahas mengenai efektivitas dan efisiensi mesin yang digunakan untuk produksi obat-obatan di PT. Soho Industri Pharmasi, penelitian ini merupakan penelitian kuantitatif dengan cara pengamatan langsung dan dengan melakukan perhitungan terhadap waktu henti pada mesin. Hasil penelitian ini menyarankan bahwa perlu adanya realisasi perubahan dari desain tranfer conveyor dan perlu adanya standarisasi dari sistem transfer conveyor tersebut agar mencapai potensi yang diinginkan. Berdasarkan pengamatan yang telah dilakukan dapat disimpulkan bahwa yang menyebabkan terjadinya penurunan OEE adalah loss time yang disebabkan oleh planned stoppages berupa waktu istirahat yang lebih dari 30 menit dan pergantian shift. Kemudian unplanned stoppages, berupa kendala pada jembatan penghubung yang tidak rata dan lengket yang dapat menhambat supply. Perbaikan pada sistem pergantian shift dan waktu istirahat serta desain transfer conveyor diharapkan dapat menjadi solusi dari permasalahan tersebut.

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This study discusses the effectiveness and efficiency of machines used for the production of drugs at PT Soho Industri Pharmasi, this research is a quantitative study by direct observation and by calculating the downtime on the machine. The results of this study suggest that there is a need for the realization of changes from the transfer conveyor design and the need for standardization of the transfer conveyor system in order to achieve the desired potential. Based on the observations that have been made, it can be concluded that what causes a decrease in OEE is loss time caused by planned stoppages in the form of breaks of more than 30 minutes and shift changes. Then unplanned stoppages, in the form of constraints on uneven and sticky connecting bridges that can hamper supply. Improvements to the shift change system and rest time and transfer conveyor design are expected to be a solution to the problem."

"Bahan baku yang telah ditimbang seringkali tidak langsung dilakukan proses produksi. Hal ini dapat menimbulkan ketidakstabilan pada bahan baku, karena bahan baku telah dibuka dari kemasan primernya. Penelitian ini bertujuan untuk mengevaluasi stabilitas dan kualitas Dextromethorphan Hydrobromide selama masa penyimpanan di PT Darya-Varia Laboratoria Citeureup Plant. Metode yang digunakan mencakup analisis fisikokimia dan uji stabilitas terhadap sampel yang disimpan pada suhu dan kondisi penyimpanan yang ditentukan. Data yang diperoleh digunakan untuk menentukan masa penyimpanan optimal yang mempertahankan kualitas bahan baku sesuai dengan standar USP (United States Pharmacopeia). Sampel bahan baku yang diambil pada setiap titik pengambilan sampel sebanyak 300 gram. Karena interval pengambilan sampel adalah pada hari ke 0, hari ke 14, dan hari ke 30 maka dibutuhkan 900 gram sampel untuk satu batch studi raw material holding time.. Implikasi dari penelitian ini adalah untuk memastikan bahwa proses penyimpanan bahan baku di pabrik farmasi memenuhi persyaratan regulasi dan kualitas, serta memastikan ketersediaan bahan baku yang optimal untuk produksi obat-obatan.

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Raw materials that have been weighed are often not immediately carried out into the production process. This can cause instability in the raw material, because the raw material has been opened from its primary packaging. This study aims to evaluate the stability and quality of Dextromethorphan Hydrobromide during the storage period at the PT Darya-Varia Laboratoria Citeureup Plant. The methods used include physicochemical analysis and stability tests on samples stored at specified temperatures and storage conditions. The data obtained is used to determine the optimal storage period that maintains the quality of raw materials in accordance with USP (United States Pharmacopeia) standards. Raw material samples taken at each sampling point were 300 grams. Because the sampling interval is on day 0, day 14, and day 30, 900 grams of sample is needed for one batch of raw material holding time studies. The implication of this research is to ensure that the raw material storage process in pharmaceutical factories meets the requirements regulations and quality, as well as ensuring optimal availability of raw materials for the production of medicines."