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"Industri farmasi merupakan badan usaha yang melakukan kegiatan pembuatan obat atau bahan obat dan telah mendapatkan izin sesuai dengan ketentuan peraturan perundang-undangan. Industri farmasi dalam pembuatan obat memiliki pedoman CPOB (Cara Pembuatan Obat yang Baik) yang digunakan guna memastikan agar obat yang dihasilkan memiliki kualitas dan mutu yang sesuai dengan persyaratan serta tujuan penggunaannya. Dalam pedoman CPOB mencakup penjelasan mengenai sistem komputerisasi yang tertera pada aneks 7. Sistem komputerisasi terdiri dari sistem komputer dan fungsi atau proses yang dikendalikan. Salah satu sistem komputerisasi di PT. Medifarma Laboratories ialah Spreadsheet Laporan Kalibrasi Thermohygrometer. Dalam memastikan thermohygrometer tersebut memberikan hasil yang akurat, maka dilakukan kalibrasi. Laporan kalibrasi thermohygrometer disajikan dalam bentuk spreadsheet menggunakan aplikasi Microsoft Excel yang digunakan untuk perhitungan data hasil kalibrasi thermohygrometer. Sehingga, spreadsheet laporan kalibrasi thermohygrometer perlu dilakukan validasi untuk memastikan bahwa spreadsheet tersebut menghasilkan data yang akurat, konsisten, dan meminimalisir kesalahan dari perhitungan manual. Penelitian ini bertujuan untuk mengetahui proses penyusunan dokumen validasi sistem komputerisasi dan mengetahui hasil validasi sistem komputerisasi spreadsheet laporan kalibrasi thermohygrometer. Metode yang dilakukan dalam validasi sistem komputerisasi spreadsheet laporan kalibrasi thermohygrometer di PT. Medifarma Laboratories adalah membuat dokumen Computerised System Registration and Impact Assessment (CSRIA), User Requirement Specification (URS), Risk Assessment (RA), Validation Protocol (VP), dan Validation Report (VR). Hasil validasi spreadsheet laporan kalibrasi thermohygrometer di PT. Medifarma Laboratories sudah memenuhi kriteria dan spesifikasi yang dipersyaratkan oleh user (QA Supervisor) sehingga spreadsheet tersebut valid dan siap untuk digunakan.

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The pharmaceutical industry operates as a licensed entity engaged in manufacturing drugs or medicinal components in accordance with legal regulations. This sector adheres to GMP (Good Manufacturing Practices) guidelines to ensure the production of drugs that meet quality standards and intended purposes. The CPOB guidelines encapsulate computerized systems, including a Thermohygrometer Calibration Report Spreadsheet used at PT. Medifarma Laboratories. Calibration ensures accurate thermohygrometer results, and this calibration report is presented using Microsoft Excel, facilitating calculation of calibration data. Validation of the thermohygrometer calibration report spreadsheet is crucial to ensure accuracy, consistency, and minimize manual calculation errors. This study focuses on the process of compiling validation documents for the computerized system and evaluating the validation results of the thermohygrometer calibration report spreadsheet. The validation process at PT. Medifarma Laboratories involves creating Computerized System Registration and Impact Assessment (CSRIA) documents, User Requirement Specification (URS), Risk Assessment (RA), Validation Protocol (VP), and Validation Report (VR). The validation of the thermohygrometer calibration report spreadsheet at PT. Medifarma Laboratories confirms its adherence to user (QA Supervisor) criteria and specifications, establishing its validity and readiness for use. This validation process guarantees accurate and reliable data, enhancing the quality and reliability of thermohygrometer calibration reporting within the pharmaceutical manufacturing context. The integration of computerized system validation ensures the precision and integrity of crucial processes in the pharmaceutical industry."

"Apoteker memiliki peran penting di industri farmasi, rumah sakit, pemerintahan, distributor farmasi dan apotek. Sebelum memasuki dunia kerja dan menjalani praktik profesi, apoteker diharuskan untuk dapat memenuhi standar kompetensi apoteker Indonesia yang terdiri dari sepuluh standar kompetensi. Standar kompetensi tersebut merupakan kemampuan yang diharapkan dimiliki oleh seorang apoteker saat lulus dan masuk ke tempat praktik kerja profesi. Selain ilmu yang cukup, seorang calon apoteker juga diharapkan memiliki bekal berupa pengalaman dalam menjalankan praktik profesi apoteker, maka dari itu dilaksanakanlah Praktik Kerja Profesi Apoteker (PKPA) di PT. Guardian Pharmatama dan Apotek Roxy Pamulang selama periode Bulan Februari - Juni 2020. Setelah PKPA dilaksanakan, diharapkan calon apoteker dapat memperluas wawasan dan pemahaman terkait praktik profesi apoteker di berbagai instansi seperti industri farmasi dan apotek.

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Pharmacists have an important role in the pharmaceutical industry, hospitals, government, pharmaceutical distributors and apotek. Before entering the real of work and undergoing professional practice, pharmacists are required to have the competency standards of Indonesian pharmacists which consist of ten competency standards. This competency standard is the ability that is expected to have by a pharmacist when graduates and enters a professional work practice. Besides sufficient knowledge, a pharmacist candidate is also expected to have experience in practicing the pharmacist profession, therefore the Pharmacist Professional Work Practice (PKPA) is carried out at PT. Guardian Pharmatama and Apotek Roxy Pamulang during the period of February - June 2020. After PKPA, it is hoped that pharmacists candidates will get a knowledge of the pharmacist's professional practice in various institutions such as the pharmaceutical industry and apotek."

"Industri farmasi saat ini tidak terlepas dari sistem komputerisasi pada proses manufakturnya. Sistem komputerisasi yang digunakan untuk pembuatan obat hendaklah divalidasi. Salah satu tahapan dalam rangkaian validasi sistem komputer adalah kualifikasi instalasi dan kualifikasi operasional. Tujuan dari tugas khusus ini adalah untuk menyusun prosedur kualifikasi instalasi dan kualifikasi operasional dari sistem komputerisasi Master Change Request Online. Prosedur kualifikasi instalasi dibuat dengan cara mengidentifikasi atribut-atribut yang terdapat pada sistem bagian Master Change Request Online. Prosedur kualifikasi operasional dibuat dengan cara mengidentifikasi cara mengoperasikan sistem bagian Master Change Request Online. Prosedur disusun berdasarkan format yang sudah ada sebelumnya yang meliputi langkah pengujian, spesifikasi, dan hasil pengujian. Prosedur kualifikasi instalasi dan kualifikasi operasional sistem komputerisasi Master Change Request Online ini dibuat dalam rangka memenuhi validasi sistem komputer.

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The pharmaceutical industry is currently inseparable from computerized systems in its manufacturing process. Computerized systems used for drug manufacturing should be validated. One of the stages in the computer system validation series is installation qualification and operational qualification. The purpose of this special assignment was to prepare installation qualification procedures and operational qualifications for the Master Change Request Online computerized system. The installation qualification procedure was created by identifying the attributes contained in the Master Change Request Online system. The Operational qualification procedure was created by identifying how to operate the Master Change Request Online system. Procedures are prepared based on a pre-existing format that includes test steps, specifications, and test results. Installation qualification procedures and operational qualifications for the Master Change Request Online computerized system were made in order to fulfill computer system validation."

"Industri Farmasi merupakan suatu perusahaan yang berbentuk badan hukum dan memiliki izin untuk melakukan kegiatan produksi atau pemanfaatan sumber daya produksi, penyaluran obat, bahan obat, dan fitofarmaka, melaksanakan pendidikan dan pelatihan, dan/atau penelitian dan pengembangan (Kemenkes RI, 2018). Semua proses yang dilakukan oleh suatu Industri Farmasi harus memenuhi persyaratan serta berpedoman pada Cara Pembuatan Obat yang Baik (CPOB) (BPOM RI, 2018). CPOB mencakup seluruh aspek produksi salah satunya yaitu kualifikasi dan validasi. PT. Sydna Farma merupakan salah satu industri farmasi yang telah rutin melaksanakan proses kualifikasi dan validasi diantaranya yaitu kualifikasi kinerja Heating Ventilation and Air Conditioner (HVAC). Sistem HVAC merupakan sistem tata udara yang digunakan untuk mengontrol kondisi atau suhu lingkungan pada suatu ruangan atau area tertutup, baik itu bangunan, gudang, ataupun kendaraan komersial (WHO, 2018). Pelaksanaan proses rekualifikasi di PT. Sydna Farma dilakukan oleh departemen bagian validasi yang dibawahi langsung oleh bagian Quality Assurance (QA). Berdasarkan pengamatan yang telah dilakukan selama kegiatan PKPA di PT. Sydna Farma, dapat disimpulkan bahwa proses rekualifikasi kinerja HVAC di ruang tableting estrogen telah dilakukan mengikuti protokol yang berlaku di PT. Sydna Farma dan telah sesuai dengan ketentuan Cara Pembuatan Obat yang Baik (CPOB).

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The Pharmaceutical Industry is a company that is a legal entity and has a permit to carry out production activities or utilize production resources, distribute drugs, medicinal ingredients, and phytopharmaca, carry out education and training, and/or research and development (Kemenkes RI, 2018). All processes carried out by a pharmaceutical industry must meet the requirements and be guided by Good Drug Manufacturing Practices (GMP) (BPOM RI, 2018). GMP covers all aspects of production, one of which is qualification and validation. PT. Sydna Farma is one of the pharmaceutical industries that has routinely carried out a qualification and validation process including the Heating Ventilation and Air Conditioner (HVAC) performance qualification. The HVAC system is an air conditioning system that is used to control environmental conditions or temperature in a room or closed area, be it a building, warehouse or commercial vehicle (WHO, 2018). Implementation of the requalification process at PT. Sydna Farma is carried out by the validation department which is directly supervised by the Quality Assurance (QA) section. Based on the observations that have been made, it can be concluded that the HVAC performance requalification process in the estrogen tableting room has been carried out following the applicable protocol at PT. Sydna Farma and complies with the provisions of Good Drug Manufacturing Practices (GMP).

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"Industri farmasi merupakan badan usaha yang memiliki izin dari Menteri Kesehatan untuk melakukan kegiatan pembuatan obat atau bahan obat. Dalam Peraturan BPOM Nomor 23 Tahun 2022 Pasal 4 ayat (2), disebutkan bahwa dalam hal standar dan/atau persyaratan mutu obat dan bahan obat terdapat lebih dari satu farmakope yang diterapkan di negara lain atau pedoman/ketentuan yang berlaku secara internasional, suatu industri obat memilih standar dan/atau persyaratan mutu yang memiliki parameter uji yang lebih lengkap, serta menggunakan metode yang lebih unggul dalam ketepatan, kepekaan, presisi, selektivitas/spesifitas, dan/atau otomatisasi. Maka dari itu, perlu dilakukan analisis perbandingan metode analisis pada Farmakope Indonesia edisi VI (FI VI) dan United States Pharmacopeia 2022 (USP NF 2022) yang merupakan farmakope/kompendial dari negara lain yang berlaku secara internasional untuk menentukan metode analisis yang lebih unggul untuk digunakan di PT Kalbe Farma Tbk. Penyusunan tugas khusus dilakukan dengan cara membandingkan monografi bahan baku obat atau obat yang terdapat di kompendial FI VI dan USP NF 2022, yaitu Propilparaben (Nipasol), Klorobutanol, dan Pektin. Berdasarkan penelitian yang telah dilakukan, metode yang lebih unggul dalam penetapan kadar Propilparaben (Nipasol) adalah dengan menggunakan High Performance Liquid Chromatography (HPLC) berdasarkan metode analisis USP NF 2022, metode yang lebih unggul dalam penetapan kadar Klorobutanol adalah dengan menggunakan Kromatografi Gas (GC) berdasarkan metode analisis USP NF 2022, dan metode yang lebih unggul dalam identifikasi Pektin adalah dengan menggunakan Spektrofotometri UV-Vis berdasarkan metode analisis USP NF 2022.

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The pharmaceutical industry is a business entity that has a permit from the Minister of Health to carry out activities to manufacture drugs or medicinal ingredients. In BPOM Regulation Number 23 of 2022 Article 4 paragraph (2), it is stated that in terms of standards and/or requirements for the quality of drugs and medicinal substances there is more than one pharmacopeia that is applied in other countries or guidelines/provisions that apply internationally, a drug industry choosing standards and/or quality requirements that have more complete test parameters, as well as using methods that are superior in accuracy, sensitivity, precision, selectivity/specificity, and/or automation. Therefore, it is necessary to carry out a comparative analysis of analytical methods in the Indonesian Pharmacopeia VI edition (FI VI) and the United States Pharmacopeia 2022 (USP NF 2022) which are pharmacopeias/compendials from other countries that apply internationally to determine which analytical method is superior to use. at PT Kalbe Farma Tbk. The preparation this assignment is carried out by comparing the monographs of medicinal raw materials or drugs contained in compendial FI VI and USP NF 2022, namely Propylparaben (Nipasol), Chlorobutanol, and Pectin. Based on the research that has been done, the method that is superior in determining Propylparaben (Nipasol) levels is to use High Performance Liquid Chromatography (HPLC) based on the USP NF 2022 analysis method, the method that is superior in determining Chlorobutanol content is to use Gas Chromatography (GC) based on the USP NF 2022 analysis method, and a superior method in identifying pectin is to use UV-Vis Spectrophotometry based on the USP NF 2022 analysis method."

"Produk rantai dingin merupakan jenis produk yang dikontrol suhunya baik dari tahap produksi hingga ke konsumen terakhir. Pedagang Besar Farmasi (PBF) adalah jenis perusahaan di Indonesia yang berperan dalam penanganan hingga pendistribusian produk farmasi salah satunya produk rantai dingin. Menurut PerKa BPOM nomor 6 tahun 2020, PBF diwajibkan memiliki sertifikat CDOB (cara distribusi obat yang baik) sebelum kegiatan operasional untuk memastikan bahwa PBF dapat menjamin kualitas obat dengan baik. PT Kimia Farma Trading and Distribution cabang Jakarta 3 termasuk salah satu PBF yang telah memiliki sertifikat CDOB untuk produk rantai dingin. Tujuan dari laporan PKPA ini adalah untuk menganalisis kesesuaian prosedur penyimpanan produk rantai dingin serta pelaksanaan pemetaan chiller di KFTD cabang Jakarta 3. Analisis dilakukan berdasarkan observasi terkait penyimpanan produk rantai dingin dan kegiatan pemetaan suhu (temperature mapping) pada chiller. Berdasarkan analisis diketahui bahwa prosedur penyimpanan produk rantai dingin telah sesuai dengan pendoman CDOB yang berlaku. Selain itu, hasil pemetaan suhu didapatkan bahwa titik yang diuji telah masuk dalam rentang suhu yang dipersyaratkan yaitu 2°C-8°C.

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Cold chain products are a type of product whose temperature is controlled from the production stage to the final consumer. Pharmaceutical wholesalers (PBF) are a type of company in Indonesia that plays a role in the handling and distribution of pharmaceutical products, one of which is cold chain products. According to PerKa BPOM number 6 of 2020, PBF must have a CDOB (good drug distribution method) certificates before operation to ensure that PBF can properly guarantee the drug quality. PT Kimia Farma Trading and Distribution branch Jakarta 3 is one of the PBFs that already has CDOB certificates for cold chain products. The purpose of this PKPA report is to analyze the suitability of cold chain product storages procedure and the implementation of chiller mapping at KFTD branch Jakarta 3. The analysis was conducted based on observations of cold chain product storages and temperature mapping activities in chillers. Based on the analysis, it is known that the procedures for storing cold-chain products comply with the applicable CDOB guidelines. Furthermore, the temperature mapping results showed that the tested points were within the required temperature range that is 2°C-8°C."

"[ABSTRAK Praktik Kerja Profesi dilaksanakan di PT. Medifarma Laboratories yangberlangsung pada periode 01 Februari ? 30 Maret 2015. Kegiatan PKP inibertujuan agar mahasiswa profesi apoteker dapat melihat langsung kegiatan diindustri farmasi, memperoleh pengetahuan dan wawasan tentang segala aspekterkait industri farmasi terutama dalam hal penerapan CPOB dan memahamiperan dan tugas apoteker di industri farmasi. Tugas khusus yang diberikanberkaitan dengan forced degradation studi yang bertujuan untuk mengetahuikemampuan metode analisis dalam mengukur respon analit dengan adanyamatriks sampel dan cemaran yang spesifik sehingga dapat digunakan sebagaimetode analisa rutin untuk pengujian kadar obat pada sampel stability. ABSTRACT Professional Internship was held at PT. Medifarma Laboratories on February 1st

? March 30th 2015. This Professional Internship is aimed to allow the apothecary

profession students to see directly the activity in the pharmaceutical industry, to

gain knowledge and insight at all aspects related to the pharmaceutical industry

especially in terms of the GMP implementation, and to understand the role and

duties of pharmacist in the pharmaceutical industry. The theme of special

assignment that is given is about Forced Degradation studies with the purpose of

study to determine any various degradant in drug product and to find out stability

of drug product in order to generate ore stable formulations.;Professional Internship was held at PT. Medifarma Laboratories on February 1st

? March 30th 2015. This Professional Internship is aimed to allow the apothecary

profession students to see directly the activity in the pharmaceutical industry, to

gain knowledge and insight at all aspects related to the pharmaceutical industry

especially in terms of the GMP implementation, and to understand the role and

duties of pharmacist in the pharmaceutical industry. The theme of special

assignment that is given is about Forced Degradation studies with the purpose of

study to determine any various degradant in drug product and to find out stability

of drug product in order to generate ore stable formulations.;Professional Internship was held at PT. Medifarma Laboratories on February 1st

? March 30th 2015. This Professional Internship is aimed to allow the apothecary

profession students to see directly the activity in the pharmaceutical industry, to

gain knowledge and insight at all aspects related to the pharmaceutical industry

especially in terms of the GMP implementation, and to understand the role and

duties of pharmacist in the pharmaceutical industry. The theme of special

assignment that is given is about Forced Degradation studies with the purpose of

study to determine any various degradant in drug product and to find out stability

of drug product in order to generate ore stable formulations., Professional Internship was held at PT. Medifarma Laboratories on February 1st

– March 30th 2015. This Professional Internship is aimed to allow the apothecary

profession students to see directly the activity in the pharmaceutical industry, to

gain knowledge and insight at all aspects related to the pharmaceutical industry

especially in terms of the GMP implementation, and to understand the role and

duties of pharmacist in the pharmaceutical industry. The theme of special

assignment that is given is about Forced Degradation studies with the purpose of

study to determine any various degradant in drug product and to find out stability

of drug product in order to generate ore stable formulations.]"