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Artykuły w czasopismach na temat „GMP (good manufacturing practice)”

Autor: Grafiati

Data publikacji: 3 czerwca 2025

Data aktualizacji: 31 lipca 2025

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1

Vijay, Kumar, Bist Meenu, Banyal Arti, and Patial Kirti. "Golden Rules of Good Manufacturing Practice (GMP)." Journal of Pharma and Drug Regulatory Affairs 1, no. 1 (2019): 30–37. https://doi.org/10.5281/zenodo.2575336.

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<em>The basic rules in any good manufacturing practice (GMP) regulations postulate that the pharmaceutical manufacturer must maintain appropriate documentation and records. Documentation helps to build up a detailed interpretation of what a manufacturing function has done in the past and what it is doing now and, thus, it provides a base for planning what it is going to do in the future. Regulatory evaluators, during their inspections of manufacturing sites, often devote much time on examining a company’s documents and records. Effective documentation boosts the visibility of the quality

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Clark, Andrew P. Z., Hong Dixon, Norma L. Cantu, Larry A. Cabell, and Joe A. McDonough. "Good Manufacturing Practice." International Journal of Toxicology 32, no. 4_suppl (2013): 18S—29S. http://dx.doi.org/10.1177/1091581813490204.

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We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1′-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously develope

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Kell, Douglas B., and Bernhard Sonnleitner. "GMP — good modelling practice: an essential component of good manufacturing practice." Trends in Biotechnology 13, no. 11 (1995): 481–92. http://dx.doi.org/10.1016/s0167-7799(00)89006-x.

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Satrio, Danang, and Wenti Ayu Sunarjo. "ANALISIS MUTU PRODUK UMKM MELALUI PENERAPAN GOOD MANUFACTURING PRACTICE." Derivatif : Jurnal Manajemen 17, no. 2 (2023): 320–28. https://doi.org/10.24127/jm.v17i2.1854.

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Salah satu upaya untuk mendorong dan mengembangkan industri-industri pengolahan skala kecil agar dapat memiliki mutu baik, aman dikonsumsi, tersedia secara berkesinambungan, dan berdaya saing tinggi secara ekonomis serta sesuai dengan selera masyarakat yaitu dengan mengendalikan proses pengolahan melalui sistem manajemen keamanan pangan berupa program kelayakan dasar berdasarkan konsep program manajemen mutu terpadu yaitu penerapan cara produksi pangan yang baik (CCPB) atauGood Manufacturing Practices(GMP). Tujuan dari penelitian ini adalah untuk Penelitian bertujuan mengidentifikasi penerapan

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Kuswardhani, Nita, Nidya Shara Mahardika, and Adine Rara Salsabila. "ANALISIS PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PADA PROSES PRODUKSI ROTI GEMBONG." Jurnal Penelitian Sains dan Teknologi Indonesia 3, no. 2 (2024): 357–68. https://doi.org/10.19184/jpsti.v3i2.1567.

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Perkembangan industri di Indonesia terus meningkat seiring dengan teknologi dan sistem produksi yang menunjang industri saat ini. Roti Gembong Hamasah merupakan salah satu perusahaan perseorangan yang bergerak di bidang pangan yaitu Roti Gembong. Evaluasi GMP mencakup 18 aspek seperti lokasi, bangunan, sanitasi, mesin, bahan, pengendalian proses, produk akhir, laboratorium, karyawan, pengemasan, label, penyimpanan, pemeliharaan, transportasi, dokumentasi, pelatihan, penarikan produk, dan penerapan pedoman. Analisis kesenjangan dengan metode gap analysis menunjukkan skor penerapan GMP sebesar 7

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Rampal, Abhimanyu, and S. P. Yamini Kanti. "Good Manufacturing Practice (GMP): History, structure and its significance." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 66–72. http://dx.doi.org/10.22270/ijdra.v8i4.439.

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Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food, Cosmetics, Pharmaceuticals products, Medical Devices & Dietary products should follow these guidelines in order to be sure that their product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories may vary but there is only one aim & that is to prevent any kind of harm that can occur to the final user of the product.

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Kartika, Kartika, cecep abdul cholik,, and Sandi Kurnia. "ANALISA PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) PRODUK OLAHAN ROTI (STUDI KASUS: SAE ROTI KUNINGAN)." Jurnal Fakultas Teknik 5, no. 2 (2024): 80–88. http://dx.doi.org/10.70476/jft.v5i2.6.

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Good Manufacturing Practice (GMP) is a reference for every food processing industry so that it can pay attention to food safety so that it can produce quality and healthy food for consumption. This research aims to: (1) determine the implementation of the Good Manufacturing Practice (GMP) system at SAE ROTI. (2) Identifying errors and deviations in the implementation of Good Manufacturing Practice (GMP) at SAE ROTI. (3) Providing solutions and recommending improvements to errors in implementing Good Manufacturing Practice (GMP). This research was conducted using qualitative methods. Data colle

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Avani, Reddy Alla, T. Cherian Kevin, Surapaneni Ramya, et al. "ROLE OF LOCAL MANUFACTURERS AND COMPETENT AUTHORITIES IN THE GOOD MANUFACTURING PRACTICE." International Journal of Current Pharmaceutical Review and Research 14, no. 01 (2022): 89–92. https://doi.org/10.5281/zenodo.12666223.

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Good Manufacturing Practice (GMP) is a set of quality control and assurance principles andguidelines that are essential in the manufacturing of pharmaceutical, biotechnological, andmedical device products. GMP ensures that these products are consistently produced andcontrolled according to established quality standards to ensure their safety, efficacy, andquality. Local manufacturers are responsible for understanding and complying with the GMPregulations and guidelines set by the regulatory authorities in their respective countries. Theymust ensure that their manufacturing processes, facilitie

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Sitepu, Syawal, Yulia Annisa, Raichan Izzati, Siti Shofiya Nasution, Durrah Hayati, and Ida Rosita. "Evaluasi Penerapan Good Manufacturing Practice (GMP) di Industri Kopi (studi kasus UD. XYZ)." Jurnal Ilmiah Mahasiswa Pertanian 9, no. 2 (2024): 106–13. https://doi.org/10.17969/jimfp.v9i2.30335.

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Good Manufacturing Practices (GMP) is a guideline that emphasizes food safety aspects for the Home Industry (IRT) to produce food that is good quality, safe and good for consumption. UD. XYZ is one of the arabica coffee producers located in Takengon, Central Aceh. Coffee processing at UD. XYZ starts from receiving raw materials which are then continued with grinding, washing, drying, and packaging to become green coffee beans that are ready to be distributed and marketed to the public. This study aims to evaluate the implementation of GMP at UD. XYZ. The results showed that UD. XYZ has impleme

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Shlopak, L. B. "Standards of Good Clinical Practice (GCP)." Spravočnik vrača obŝej praktiki (Journal of Family Medicine), no. 6 (May 28, 2023): 23–28. http://dx.doi.org/10.33920/med-10-2306-03.

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In the Eurasian Economic Union, the unified rules of Good Clinical Practice (GCP) came into force on May 6, 2017. These rules relate primarily to the circulation of medicines, and, along with good manufacturing practice (GMP) and good laboratory practice (GLP), are fundamental in matters of standardizing the quality of medical care for the population. The scope of these rules covers clinical trials of medicines, where the “subject” is an individual, and affects the ethical and moral aspects of conducting such trials [4]. Compliance with these rules is necessary when conducting clinical trials,

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Erliana, Cut Ita, Iskandar Hasanuddin, Yuwaldi Away, and Raja Ariffin Raja Ghazilla. "Good Manufacturing Practice (GMP) in Tofu MSMEs in North Aceh." SINERGI 27, no. 3 (2023): 443. http://dx.doi.org/10.22441/sinergi.2023.3.015.

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This study examined tofu MSMEs in Lhokseumawe City and the North Aceh District. Observations indicate discrepancies between tofu production and the GMP requirements for Good Manufacturing Practices. The amount that the tofu sector has adopted appropriate food production procedures by the Regulation of the Ministry of Sector of the Republic of Indonesia Number 75/M-IND/PER/7/2010 is determined using a GMP approach. This research is anticipated to improve the product safety of the tofu industry and provide recommendations for improvement. In this study, data collection techniques included candid

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Huda, Listiani Nurul, and Rifqi Athaullah. "Ergonomic analysis through good manufacturing practice (gmp) training (case: Binjai MSME)." E3S Web of Conferences 332 (2021): 05002. http://dx.doi.org/10.1051/e3sconf/202133205002.

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The work environment is one of the most important factors in production. In this paper, a study was conducted on the work environment in MSMEs to determine the safety and health of the work environment in producing products. Specifically, the study was conducted to see the deviation in the application of GMP in MSME. The subjects were 30 MSMEs involved in the research from Binjai Municipalities. This study uses a qualitative analysis method that aims to evaluate the level of application of 14 aspects of GMP and find out the understanding of MSMEs on aspects of GMP. The analysis results show th

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Kurniasari, Nur Itsna, Silvia Oktavia Nur Yudiastuti, and Ricky Jadi Rezeqi. "Analisis Penerapan Good Manufacturing Practice (GMP) di CV. Buana Citra Sentosa, Yogyakarta." JOFE : Journal of Food Engineering 1, no. 3 (2022): 130–39. http://dx.doi.org/10.25047/jofe.v1i3.3279.

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GMP application is used to support the industry to be responsible for the products produced. In addition, by implementing GMP, the competitiveness of the industry will increase. The application analysis of the GMP in CV. Buana Citra Sentosa aims to provide solutions caused by GMP deviations in the industry. The method used in analyzing the GMP application is the scoring method with the AHP (Analytical Hierarchy Process) method approach. The results of the evaluation can be used to determine the compatibility of GMP implementation. Based on the GMP feasibility level assessment, CV. Buana Citra

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Poli, Michela, Mauro Quaglierini, Alessandro Zega, et al. "Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations." Applied Sciences 14, no. 4 (2024): 1584. http://dx.doi.org/10.3390/app14041584.

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Risk assessment and management during the entire production process of a radiopharmaceutical are pivotal factors in ensuring drug safety and quality. A methodology of quality risk assessment has been performed by integrating the advice reported in Eudralex, ICHQ, and ISO 9001, and its validity has been evaluated by applying it to real data collected in 21 months of activities of 18F-FDG production at Officina Farmaceutica, CNR-Pisa (Italy) to confirm whether the critical aspects that previously have been identified in the quality risk assessment were effective. The analysis of the results of t

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Edwin, Tivany, Reinny Patrisina, Alexie Herryandie Bronto Adi, Prima Fithri, and Nindy Hidayah. "Pelatihan Good Manufacturing Practice (GMP) pada Usaha Pangan Binaan Universitas Andalas." Jurnal Warta Pengabdian Andalas 27, no. 1 (2020): 1–5. http://dx.doi.org/10.25077/jwa.27.1.1-5.2020.

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Food business is a very promising, but the products must be safe and worth buying. Good manufacturing practices (GMP) are production practices which considering various aspects, such as preventing food contamination during the production process, and production control as well. Small and Medium Enterprises (SME) fostered by Andalas University, which is engaged in the field of food manufacturing, wants to find its products better known and with a wide sales distribution. This can be realized if the business owner has the trust of many consumers. One effort that can be done is to implement the G

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Sari, Indriani Purnama, Nil E. Maitimu, and Alfredo Tutuhatunewa. "PENERAPAN GOOD MANUFACTURING PRACTICE PADA PERUSAHAAN AIR MINUM DALAM KEMASAN." i tabaos 3, no. 1 (2023): 9–16. http://dx.doi.org/10.30598/i-tabaos.2023.3.1.9-16.

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Air minum yang sehat merupakan suatu kebutuhan yang tidak dapat ditinggalkan dan sangat penting bagi kehidupan manusia serta seluruh makhluk hidup karena dibutuhkan dalam berbagai macam kebutuhan seperti pertanian dan perindustrian. tujuan dari penelitian ini yaitu Menganalisis penerapan Good Manufacturing Practice di CV. Abadi Tiga Mandiri. Penilaian penerapan GMP terdiri dari identifikasi kondisi nyata pada ruang lingkup produksi AMDK di CV. Abadi Tiga Mandiri berdasarkan ruang lingkup GMP sesuai dengan peraturan Menteri perindustrian republik Indonesia NO. 75/M-IND/PER/7/2010. Jumlah ruang

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Amelia Sofianty, Ardhia Putri, and Jariyah Jariyah. "Penguatan Good Manufacturing Practice (GMP) Melalui Kegiatan Edukasi Hingga Evaluasi di PT. XYZ." Jurnal Pengabdian Masyarakat Indonesia 4, no. 1 (2024): 9–15. http://dx.doi.org/10.52436/1.jpmi.1476.

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XYZ merupakan perusahaan BUMN yang memfokuskan produksinya pada produksi teh. Produk utama teh yang diproduksi adalah teh hitam, teh hijau dan teh putih. Untuk menjalankan produksi dan menjaga kualitas pada produk teh yang dihasilkan, PT. XYZ melaksanakan persyaratan dasar yaitu penerapan Good Manufacturing Practice (GMP). Namun, masalah yang dihadapi adalah ditemukan ketidaksesuaian pada lapangan dengan aspek GMP yang diterapkan. Sehingga hal tersebut mendukung dilakukannya kegiatan ini untuk memberikan edukasi dan evaluasi aspek GMP pada karyawan pabrik PT. XYZ. Kegiatan ini dilakukan melalu

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Tulina, M. A., and N. V. Pyatigorskaya. "Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products." Bulletin of Experimental Biology and Medicine 164, no. 4 (2018): 579–82. http://dx.doi.org/10.1007/s10517-018-4035-8.

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Aziza, Farida. "Comparison Review of Two Regulatory Agencies Regulation: Therapeutic Goods Administration (TGA) and the European Medicine Agency (EMA) in Relation to Good Manufacturing Practice (GMP) Guideline." Majalah Farmaseutik 17, no. 2 (2021): 243. http://dx.doi.org/10.22146/farmaseutik.v17i2.60237.

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There are some regulatory bodies in the world that impacting the pharmaceutical industry to operate and perform Good Manufacturing Practice (GMP) principles. These regulatory bodies exist to ensure that the pharmaceutical product and other human supporting products have a high standard of quality, safety, and efficacy from product registration to product distribution to the patient. This article reviews some aspects which is regulated by two of regulatory entities including Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA) in relation with Good Manufacturing Practice (

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Mela, Ervina, and Dian Dwi Novianti. "Good Manufacturing Practices in Black Tea Processing at PT. XYZ." Indonesian Journal of Food Technology 2, no. 1 (2023): 16. http://dx.doi.org/10.20884/1.ijft.2023.2.1.7232.

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Black tea comes from perfectly fermented tea leaves and is one of Indonesia's main export commodities. The high level of black tea exports requires producers to produce high-quality products. One way to realize quality and safe products is by implementing Good Manufacturing Practices (GMP). The purpose of this study was to determine the application of Good Manufacturing Practices (GMP) in black tea processing at PT XYZ. The research method was carried out by collecting primary and secondary data. Primary data were obtained through direct observation and practice in the field, as well as interv

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Zuwarman, Dwi, Sutrisno Suro Mardjan, and Rokhani Hasbullah. "Evaluasi Mutu Beras dengan Kesesuaian Good Handling Practices dan Good Manufacturing Practices di Kabupaten Bogor." Jurnal Keteknikan Pertanian 8, no. 1 (2020): 1–8. http://dx.doi.org/10.19028/jtep.08.1.1-8.

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Milled rice is one of the most important agricultural commodities for Indonesian people as staple food. Consumers tend to not know how to differentiate good or low quality of rice. Rice mill (RMU) in Bogor Regency mostly do not have quality standard comply with Indonesian National Standard (SNI). The purpose of this study was to identify the quality of rice and milled rice produced by RMU in Bogor Regency and evaluate the suitability of the application of rice and milled rice handling in RMU to Good Handling Practices (GHP) and Good Manufacturing Practices (GMP). The parameters measured were a

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Tomiyoshi, Katsumi, Yuta Namiki, David J. Yang, and Tomio Inoue. "Production, Validation, and Exposure Dose Measurement of [13N]Ammonia Under Academic Good Manufacturing Practice Environments." Pharmaceutics 17, no. 5 (2025): 667. https://doi.org/10.3390/pharmaceutics17050667.

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Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing of PET drugs in hospitals and clinics, regardless of the cGMP environment. Without adequate facilities, equipment, and personnel required by cGMP regulations, the quality assurance (QA) and clinical effectiveness of PET drugs largely depend on the radiosynthesizers themselves. To bridg

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Dr., Someshwar Mankar* Riya Chabukswar Arti Chaudhari Sakshi Chavan Yuvraj Chavan Payal Chavhanke. "A Review Article ON: cGmp Signaling: A Contemporary Overview and Future Direction." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 2431–37. https://doi.org/10.5281/zenodo.15257931.

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GMP (Good Manufacturing Practice) is a system for ensuring that products&ensp;are produced and controlled consistently against&ensp;quality standards. Its reduce risks in&ensp;the manufacture of pharmaceuticals, guaranteeing products&ensp;are safe, effective and high quality. GMP has four key aspects to make&ensp;this work aspect Raw Material Quality, ensures material is known, is processed, and free&ensp;from contamination;&ensp;Risk Assessment, preventing and managing risks in pharmaceutical production; Inspections,&ensp;routine inspections of manufacturing sites in terms of actions&ensp;tak

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Tomić, Siniša, Anita Sučić, and Adrijana Martinac. "Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities." Archives of Industrial Hygiene and Toxicology 61, no. 4 (2010): 425–36. http://dx.doi.org/10.2478/10004-1254-61-2010-2035.

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Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, inclu

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Yuliana, Neti, Dewi Sartika, and Teguh Setiawan. "Pendampingan Good Manufacturing Practice Pada IKM Kerupuk Kemplang Ummy Nissa, Gedung Tataan–Kabupaten Pesawaran." Jurnal Pengabdian Kepada Masyarakat (JPKM) TABIKPUN 3, no. 1 (2022): 1–10. http://dx.doi.org/10.23960/jpkmt.v3i1.56.

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Ummy Nissa, merupakan salah satu IKM yang memproduksi kerupuk kemplang yang terletak di Gedung Tataan, Kabupaten Pesawaran. Pelaku usaha Ummy Nissa belum mengenal dan memahami bagaimana cara berproduksi pangan yang baik, sehingga memerlukan pendampingan dalam penerapan Good Manufacturing Practice (GMP). Kegiatan pendampingan dilakukan dengan tahapan: (1) evaluasi pelaksanaan GMP pada IKM Ummy Nissa, (2) pelatihan GMP melalui ceramah dan diskusi, dan (3) praktik berproduksi sesuai dengan GMP. Prinsip prinsip GMP mengacu pada surat keputusan menteri RI No: 23/Men.Kes/SK/I/1978 tentang pedoman ca

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Irawan, N. C., S. S. Heriyanti, and RB Esthi. "Unlocking eco-industry: green knowledge and good manufacturing practice fish scale waste utilization." IOP Conference Series: Earth and Environmental Science 1267, no. 1 (2023): 012081. http://dx.doi.org/10.1088/1755-1315/1267/1/012081.

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Abstract Scales such as fish waste are considered worthless, even though they can be used as raw materials for collagen-making. This fish waste management process also contributes to reducing the problem of environmental pollution due to the disposal of fish waste that is not managed correctly. This study aims to determine the relationship between green knowledge upskilling (GKU) of employees, good manufacturing practice (GMP), and eco-performance (EP). The research site was determined by conducting a census of the 35 personnel at PT Marine Biogel Indonesia in Boyolali. The research model uses

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Sato, Keigo, Kota Kodama, and Shintaro Sengoku. "Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan." International Journal of Environmental Research and Public Health 17, no. 13 (2020): 4748. http://dx.doi.org/10.3390/ijerph17134748.

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Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement

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Amelia, Maya, and Annis Adi. "HUBUNGAN SIKAP PENJAMAH MAKANAN DENGAN CARA PRODUKSI PANGAN YANG BAIK PADA INDUSTRI RUMAH TANGGA PANGAN DI KAMPUNG KUE SURABAYA[Correlation of Food Handlers Attitude with Good Manufacturing Practice in the Household Food Industry in Kampung Kue Surabaya]." Media Gizi Indonesia 14, no. 2 (2019): 140. http://dx.doi.org/10.20473/mgi.v14i2.140-146.

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The application of Good Manufacturing Practice (GMP) can improve quality of products. Good manufacturing practice aim to make a safe product to be consumed. Attitude of food handlers can affect practice of food handlers on production process. The purpose of this study was to analyze the correlation between attitude of food handlers with GMP. This research was an observational study, using cross sectional design. Subjects were 38 food handlers, taken by simple random sampling. Data were collected include interview method using attitude questionnaires and observation of the GMP. Data were analyz

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Wahid, Abdul. "Improving the Quality of Tempe Products with GMP and Model Based Integrated Process Improvement In SME’s Pacarkeling." JKIE (Journal Knowledge Industrial Engineering) 8, no. 1 (2021): 1–9. https://doi.org/10.35891/jkie.v8i1.2487.

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Small and Medium Enterprises, Tempe Pacarkeling is one of the centers for Small and Medium Enterprises in Pasuruan. This Small and Medium Enterprise Center is located in Pacarkeling-Kejayan-Pasuruan Village. One of the UKM that was used as the research object was the Tempe UKM owned by Mr. Muizzi. In the production process, there is still less attention to environmental cleanliness. So it requires an assessment of Good Manufacturing Practice (GMP) as an assessment of the environment and working conditions. In addition, this study aims to evaluate the level of application of GMP. Based on the r

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Trisna Putra, Andre Yusuf, Hadi Munarko, and Dina Mustika Rini. "SOSIALISASI GOOD MANUFACTURING PRACTICE PADA PRODUKSI SAMBEL RUJAK CINGUR INSTAN DI UMKM BURIRI." Environmental Engineering Journal of Community Dedication 4, no. 1 (2024): 20–23. http://dx.doi.org/10.33005/environation.v4i1.18.

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Good manufacturing practice (GMP) adalah komponen penting dalam menjaga mutu dan keamanan produk pangan. Usaha Mikro Kecil Menengah (UMKM) Buriri adalah produsen sambel rujak cingur instan di Surabaya. UMKM tersebut belum memiliki pengetahuan tentang cara menjaga kualitas produk yang baik dan belum menerapkan manajemen mutu yang baik dalam proses produksi. Sehingga diperlukan program sosialisasi dan pendampingan berbasis GMP guna meningkatkan mutu dan kemananan produk sambel rujak cingur instan. Kegiatan pengabdian dilaksanakan pada tanggal 9 Agustus 2022. Metode yang dilakukan adalah penyuluh

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Boghi, Cláudio, Dorlivete Moreira Shitsuka, Marcos Alexandruk, Ricardo Shitsuka, and Paulo Roberto Rela. "Good manufacturing practices (gmp) utilized on human blood irradiation process." Exacta 6, no. 1 (2009): 35–40. http://dx.doi.org/10.5585/exacta.v6i1.800.

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Irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of lymphocytes. The implementation of the GMP will assure that the properly dose in a range of 25Gy to 50Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies to establish the GMP were developed under the guidelines of the standard ISO 11137 – Sterilization

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Alya Julia Rahma, Muhammad Sabda Anggowo Bekti, Raihan Pramudya AnanTatur Noci, and Sari Widyautami. "ANALISIS TATA LETAK PROSES PRODUKSI TAHU DAN PENERAPAN GOOD MANUFACTURING PRACTICE PADA UMKM TAHU SUTRA DI KOTA CILACAP." Jurnal Agroindustri Pangan 3, no. 2 (2024): 68–78. http://dx.doi.org/10.47767/agroindustri.v3i2.757.

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Penelitian ini dilakukan dengan tujuan untuk menganailis tata letak proses produksi dan penerapan Good Manufacturing Practice (GMP) pada UMKM Tahu Sutra. Metode penelitian yang digunakan dalam menganalisis tata letak proses produksi tahu dan penerapan Good Manufacturing Practice (GMP) menggunakan metode observasi secara langsung terhadap proses produksi serta wawancara dengan pemilik UMKM Tahu Sutra. Hasil observasi menunjukan bahwa tata letak proses produksi UMKM Tahu Sutra ini menggunakan tata letak later U dimana tata letak terdiri dari tempat penyimpan alat, tempat pencucian dan perendaman

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YELUBAEVA, A. Y., А. К. SADANOV, B. B. BAIMAKHANOVA, et al. "ENSURING THE QUALITY OF PHARMACEUTICAL PRODUCTION IN ACCORDANCE WITH GOOD MANUFACTURING PRACTICE REQUIREMENTS." МИКРОБИОЛОГИЯ ЖӘНЕ ВИРУСОЛОГИЯ, no. 1(48) (March 26, 2025): 103–17. https://doi.org/10.53729/mv-as.2025.01.05.

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This article presents the results of developing Kazakh national standards for Good Manufacturing Practice (GMP) in pharmaceutical production based on international standards, particularly those of the European Union. Implementation of good Manufacturing Practices (GMP) and quality system in pharmaceutical production. Ensuring a high level of quality and safety of medicines not only protects public health, but also opens up the possibility of products entering international markets. GMP controls are implemented at all stages of production—from raw material acquisition to the release of the fini

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Ways, Judy P., M. Sue Preston, Donald Baker, Jean Huxsoll, and Jason Bablak. "Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation." Biotechnology and Applied Biochemistry 30, no. 3 (1999): 257–65. http://dx.doi.org/10.1111/j.1470-8744.1999.tb00779.x.

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The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma‐fractionation industry has experienced increased compliance‐related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the imp

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Ananda. "IMPROVING THE QUALITY OF TEMPE PRODUCTS USING THE IMPLEMENTATION METHOD OF GOOD MANUFACTURING PRACTICE (GMP) AND MODEL BASED AND INTEGRATED PROCESS IMPROVEMENT (MIPI) IN TEMPE SROMO SMEs." JKIE (Journal Knowledge Industrial Engineering) 9, no. 1 (2025): 100–109. https://doi.org/10.35891/jkie.v9i1.6193.

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Mr. Muizzi's Tempe Sromo UKM is one of the largest Tempe UKM in Sromo. However, SMEs (Small and Medium Enterprises) Tempe Sromo in the production process do not pay attention to environmental cleanliness so that it affects the quality of the tempe products produced. Therefore it is necessary to carry out a Good Manufacturing Practice (GMP) assessment which aims to provide a concept of proposed improvements using the Model Based and Integrated Improvement (MIPI) method as an effort to improve the quality of the products produced. Based on the results of the Good Manufacturing Practice (GMP) ass

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Annisa, Viviane. "Kajian Penerapan Good Manucfacturing Practice (GMP) di Industri Farmasi Indonesia." Majalah Farmasetika 9, no. 4 (2024): 351–66. http://dx.doi.org/10.24198/mfarmasetika.v9i4.56576.

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Good Manufacturing Practice (GMP) merupakan salah satu golden standar dari pemerintah untuk menilai kesesuaian proses produksi dan keamanan produk. Prinsip dari GMP adalah kualitas dibangun kedalam produk, tidak hanya pada pengujian saja. Pembuatan obat di Indonesia mengacu pada standar GMP yang berlaku di Indonesia untuk industri farmasi, yakni Pedoman CPOB. Kajian ini betujuan untuk melakukan kajian tentang penerapan GMP di industri farmasi Indonesia, sehingga dapat memberikan gambaran bagaimana sistem GMP diterapkan di Indonesia. Metode penulisan artikel menggunakan berbagai referensi dari

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Anna, Zuzy, Rahmahwati Rosidah, Armida Salsiah Alisjahbana, and Robi Andoyo. "EVALUASI HASIL PELATIHAN GOOD MANUFACTURING PRACTICES (GMP) UNTUK PEREMPUAN PESISIR: ANALISIS KESEJAHTERAAN SUBJEKTIF." Jurnal Kebijakan Sosial Ekonomi Kelautan dan Perikanan 9, no. 1 (2019): 37. http://dx.doi.org/10.15578/jksekp.v9i1.7238.

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Sektor perikanan tangkap adalah sektor yang memberikan kontibusi yang cukup besar bagi perikanan Indonesia. Sektor ini diharapkan bisa menjadi peranan strategis bagi pembangunan perikanan Indonesia. Salah satu cara yang dapat dilakukan adalah peningkatan hasil perikanan tangkap. Indramayu merupakan daerah dengan hasil perikanan tangkap yang memberikan kontribusi sebesar 60% dari perikananan tangkap Jawa Barat, menjadikan Indramayu sebagai daerah dengan tingkat kontribusi produksi perikanan terbesar diantara daerah-daerah lainnya. Produksi dari aktivitas perikanan ini didapatkan rata-rata sebes

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Hidayati, Darimiyya, Umi Purwandari, and Ihsannudin -. "KAJIAN PENERAPAN GOOD MANUFACTURING PRACTICE (GMP) DI INDUSTRI KERUPUK IKAN SRESEH KABUPATEN SAMPANG MADURA." JURNAL REKAYASA DAN MANAJEMEN AGROINDUSTRI 10, no. 2 (2022): 173. http://dx.doi.org/10.24843/jrma.2022.v10.i02.p05.

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The demands of today's consumers are not only for quality but also for safe food. To improve product safety, “Industri Kecil Menengah” (IKM) must start implementing the basic level of feasibility, namely Good manufacturing practice (GMP). GMP is a basic feasibility standard that can be used to assess the level of industry feasibility. The purpose of this study was to determine the basic feasibility level of the two fish cracker industries located in Sreseh District, Sampang Regency. The research was conducted by direct observation in the field and interviews with the company's management. Ther

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Maitimu, Nil Edwin, and Marcy Lolita Pattiapon. "PENERAPAN GOOD MANUFACTURING PRACTICE PADA UD. XYZ DI KOTA TUAL." ARIKA 15, no. 2 (2021): 115–24. http://dx.doi.org/10.30598/arika.2021.15.2.115.

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Usaha kecil menengah berperan penting dalam mendukung ekonomi Nasional, terutama pada bidang pangan olahan hasil laut. Olahan hasil laut dalam bentuk abon ikan merupakan usaha home industry UD. XYZ. Kondisi usaha abon ikan akan terhambat dengan adanya kejadian-kejadian yang tidak diharapkan atau risiko negatif yang dapat menimbulkan kerugian. Hal ini berkaitan dengan proses sanitasi yang belum maksimal dalam hal sanitasi pekerja, sanitasi alat dan wadah, dan sanitasi bangunan. Penelitian ini bertujuan untuk mengiplementasikan SSOP pada proses produksi Abon Ikan dan menghasilkan produk Abon Ika

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Jassin, Ernawati, Andi Ridwan Makkulawu, Ilham Ahmad, and Imran Muchtar. "Penerapan Good Manufacturing Practices (GMP) dan Sanitation Standard Operating Prosedure (SSOP) pada UKM di Desa Jennetalassa Kabupaten Gowa." Prosiding Seminar Nasional Politeknik Pertanian Negeri Pangkajene Kepulauan 3 (December 6, 2022): 694–702. http://dx.doi.org/10.51978/proppnp.v3i1.303.

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Untuk menghasilkan produk pangan yang aman, maka dalam proses pengolahan pangan diperlukan penjaminan mutu dan keamanan pangan dengan pendekatan sistem Hazard Analysis Critical Control Point (HACCP). Di dalam HACCP, ada 2 (dua) program prasyarat yang harus dipenuhi meliputi Good Manufacturing Practices (GMP) dan Sanitation Standard Operating Procedures (SSOP). Sistem HACCP ini diterapkan selama produksi mulai dari proses pertama hingga sampai ke konsumen (Fardiaz, 1996). Program Pengabdian masyarakat ini diharapkan akan memberikan luaran sistem Good Manufactoring Practice (GMP) dan Standard Sa

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Adam Ismail Ahmed, Ibrahim Adam Osman Algazouly, and Awad Mohammed Babeker. "Assessment of the application of Good Manufacturing Practices (GMP) in some wheat mills in Sudan." International Journal of Life Science Research Archive 3, no. 1 (2022): 017–21. http://dx.doi.org/10.53771/ijlsra.2022.3.1.0058.

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The present study was conducted during the period from April to December 2018. The objectives of this work were to assess the application of Good Manufacturing Practice (GMP) in nine wheat mills in Khartoum State and one wheat mills in Elobeid - North Kordofan State. Ready questionnaire prepared by Primus Lab Checklist (2013) was used and data were categorized according to GMP system. Concerning the first part of general GMP, the result revealed that two wheat mills in Khartoum state adopted the general GMP system whereas eight wheat mills were not adopted it. Regarding pest control requiremen

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S., D. Mankar Shruti Varade Vaibhav Varghude Sagar Vendait* Atharv Vikhe Mayur Wagh. "A Review on Good Warehousing Practices." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 2287–94. https://doi.org/10.5281/zenodo.15240493.

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In the pharmaceutical industry, warehousing is an integral part of the supply chain, ensuring the safe storage, handling, and distribution of medicines and related products. Given the sensitive nature of pharmaceutical goods, warehouses must comply with stringent regulatory standards, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). This review provides an overview of the critical need for pharmaceutical warehouses, the layout considerations that support operational efficiency, and the guidelines that govern their operation. Furthermore, it highlights the benef

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Ulya, Zaudhatul, Friesca Erwan, Irfan Zikri, Fitri Deliana, and Muhammad Auza. "Evaluation of Good Manufacturing Practices (GMP) in Aceh patchouli industry." IOP Conference Series: Earth and Environmental Science 1510, no. 1 (2025): 012078. https://doi.org/10.1088/1755-1315/1510/1/012078.

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Abstract Good Manufacturing Practices (GMP) in community-based and smallholder patchouli oil production represents a positive initiative to enhance productivity and profitability while mitigating risks associated with workforces, workflows, and environment. This study aims to explore the implementation of GMP in a patchouli industry center run by community-based cooperative in Lhoong, Aceh Besar. This is a qualitative study which collect data from interviews and observations, and analyzes the data using comparative analysis. Data is classified according to the 5P indicators of GMP, which consi

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Dohong, Ita Susilawaty, Soaloon Sinaga, Betrixia Barbara, and Saputera Mardi. "Kajian Penerapan GHP (Good Handling Practices) dan GMP (Good Manufacturing Practices) Padi Terhadap Mutu Beras di Lokasi Penggilingan Padi Kawasan Food Estate Kabupaten Pulang Pisau." Jurnal Penelitian UPR 3, no. 2 (2023): 83–92. http://dx.doi.org/10.52850/jptupr.v3i2.11177.

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Beras merupakan bahan makanan pokok bagi sebagian besar masyarakat Indonesia. Seiring meningkatnya populasi penduduk, kebutuhan beras turut meningkat. Salah satu bentuk pemenuhan aspek kuantitas adalah peningkatan produksi di kawasan sentra padi sekaligus peningkatan mutu beras. Permasalahan mutu beras di antaranya adalah penerapan GHP (Good Handling Practices) dan GMP (Good Manufacturing Practices) di lokasi penggilingan padi. Penelitian ini bertujuan untuk mengkaji mutu beras yang dihasilkan penggilingan padi dan mengevaluasi tingkat kesesuaian penerapan GHP dan GMP di kawasan Food Estate ka

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Maulina Dewi, Susi, and Lia Anggraeni. "Studi Penerapan Good Manufacturing Practices (GMP) Pada Produksi Manisan Pala." Jurnal Sosial Sains 2, no. 4 (2022): 532–37. http://dx.doi.org/10.36418/jurnalsosains.v2i4.386.

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LatarBelakang: Usaha Dianti merupakan industri rumah tangga (home industry) manisan pala yang telah mendistribusikan produknya ke beberapa kota di Aceh. Luasnya pemasaran produk yang diproduksi perlu ditunjang dengan pengendalian mutu produk yang baik. Tujuan: Penelitian ini bertujuan untuk menganalisa kesesuaian praktek penerapan GMP yang sudah diterapkan di Usaha Dianti dengan standar GMP yang ditetapkan oleh pemerintah serta mengamati aspek-aspek GMP yang perlu diperbaiki dalam proses produksi manisan pala di usaha ini. Metode: Metode penelitian yang dipakai adalah pengumpulan data primer m

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Maulina Dewi, Susi, and Lia Anggraeni. "Studi Penerapan Good Manufacturing Practices (GMP) Pada Produksi Manisan Pala." Jurnal Sosial Sains 2, no. 4 (2022): 532–37. http://dx.doi.org/10.59188/jurnalsosains.v2i4.386.

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LatarBelakang: Usaha Dianti merupakan industri rumah tangga (home industry) manisan pala yang telah mendistribusikan produknya ke beberapa kota di Aceh. Luasnya pemasaran produk yang diproduksi perlu ditunjang dengan pengendalian mutu produk yang baik. Tujuan: Penelitian ini bertujuan untuk menganalisa kesesuaian praktek penerapan GMP yang sudah diterapkan di Usaha Dianti dengan standar GMP yang ditetapkan oleh pemerintah serta mengamati aspek-aspek GMP yang perlu diperbaiki dalam proses produksi manisan pala di usaha ini. Metode: Metode penelitian yang dipakai adalah pengumpulan data primer m

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He, Tian-Tian, Carolina Oi Lam Ung, Hao Hu, and Yi-Tao Wang. "Good manufacturing practice (GMP) regulation of herbal medicine in comparative research: China GMP, cGMP, WHO-GMP, PIC/S and EU-GMP." European Journal of Integrative Medicine 7, no. 1 (2015): 55–66. http://dx.doi.org/10.1016/j.eujim.2014.11.007.

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Jali, Mohd Bakri, Maaruf Abdul Ghani, and Norazmir Md Nor. "The Confusion of Design and Facilities in Good Manufacturing Practice Requirements among Industries in Malaysia." Environment-Behaviour Proceedings Journal 1, no. 3 (2016): 156. http://dx.doi.org/10.21834/e-bpj.v1i3.361.

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Food manufacturing operations need to fulfil regulatory requirements related to hygiene and Good Manufacturing Practice (GMP) to successfully market their products as safe and high quality products. GMP is a component of the food safety system to ensure the control of public hygiene and environmental conditions of the food production process. This study aims to investigate the confusion over design and facilities elements among food industries through qualitative technique. Design and facilities elements lay a firm foundation for GMP to ensure food hygiene and should be used in conjunction wit

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Rusconi, Giulio, Martina Cremona, Matteo Gallazzi, et al. "Good Manufacturing Practice-Compliant Cryopreserved and Thawed Native Adipose Tissue Ready for Fat Grafting." Journal of Clinical Medicine 13, no. 11 (2024): 3028. http://dx.doi.org/10.3390/jcm13113028.

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Background. As adipose tissue-derived mesenchymal stem cells are becoming the tool of choice for many clinical applications; standardized cryopreservation protocols are necessary to deliver high-quality samples. For this purpose, the cryopreservation and thawing of native adipose tissue under GMP conditions could represent an extremely useful and powerful tool for the direct reinfusion of the tissue, and consequently, of its stromal vascular fraction. Methods: In this study, 19 samples of adipose tissue were cryopreserved and characterized before and after storage in liquid nitrogen vapors. Of

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Sharma, Akash, Vriti Gamta, and Gaurav Luthra. "The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry." Journal of Pharmaceutical Research International 35, no. 18 (2023): 75–90. http://dx.doi.org/10.9734/jpri/2023/v35i187394.

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In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and i

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