Study of Contamination Control in The Pharmaceutical Industry Ethylene Glycol and Diethylene Glycol
Isi Artikel Utama
Abstrak
Rincian Artikel

Artikel ini berlisensiCreative Commons Attribution-ShareAlike 4.0 International License.
Penulis yang mempublikasikan artikel di Jurnal Kesehatan Lingkungan menyetujui ketentuan sebagai berikut:
- Penulis tetap memegang hak cipta dan memberikan kepada jurnal hak untuk melakukan publikasi pertama.
- Karya dilisensikan di bawah Creative Commons Attribution-ShareAlike 4.0 International License, yang mengizinkan pihak lain untuk membagikan (menyalin dan mendistribusikan ulang materi dalam media atau format apa pun) serta mengadaptasi (mengubah, mengembangkan, dan membuat karya turunan) untuk tujuan apa pun, termasuk tujuan komersial, dengan ketentuan bahwa atribusi yang tepat diberikan kepada penulis asli dan sumber, tautan ke lisensi disertakan, serta setiap perubahan yang dilakukan harus dinyatakan.
Setiap adaptasi, modifikasi, atau karya turunan wajib didistribusikan dengan lisensi yang sama (CC BY-SA 4.0), dan tidak diperkenankan menambahkan pembatasan tambahan yang dapat mengurangi hak-hak yang diberikan oleh lisensi ini. - Penulis diperkenankan untuk membuat perjanjian tambahan secara terpisah terkait distribusi non-eksklusif atas versi karya yang telah dipublikasikan oleh jurnal (misalnya, mengunggahnya ke repositori institusi atau memasukkannya ke dalam buku), dengan tetap mencantumkan bahwa karya tersebut pertama kali dipublikasikan di jurnal ini.
Referensi
Sharma DC. (2022). Cough syrup deaths expose lax drug regulation in India. The Lancet, 400(10361), 1395-1399.
BBC Indonesia. (2022). Gangguan ginjal akut: BPOM menduga produsen obat ganti pemasok bahan farmasi ke kimia ‘karena lebih murah.’ BBC News. Retrieved November 18, 2022, from https://www.bbc.com/indonesia/articles/ce4r2wy1xjzo.
Dhanapriya J, Gopalakhrishnan N, Kamarajan M, Balasubramaniyan T, Sakhtirajan T, Dineshkumar T. (2016). Diethylene glycol poisoning-induced acute kidney injury. Saudi Journal of Kidney Diseases and Transplantation, 27(6), 1276-1279.
Cotton S. (2018). Ethylene glycol (Ethane1,2-Diol) and AntiFreeze Poisoning. JSMol, 1(1), 1-6.
Patil R, Gangadharappa H V., Kiran HC, Sandhya K. (2016). Planning of hazard analysis critical control point (HACCP) in pharmaceuticals. International Journal of Pharmaceutical Science Review and Research, 37(1), 149-154.
Pramod K, Tahir Ma, Charoo N, Ansari S, Ali J. (2016). Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation, 6(3), 129-139.
Chaudhari V, Yadav V, Verma P, Singh A. (2014). A Review on Good Manufacturing Practice (GMP) for Medicinal Products. PharmaTutor, 2(9), 8-19.
Kharub M, Limon S, Sharma RK. (2018). The application of quality tools in effective implementation of HACCP. International Journal of Quality & Reliability Management, 35(9), 1920-1940.
Bansal G, Parashar B, Dhamija H. (2013). The Application Of HACCP And Risk Management In The Pharmaceutical Process. Asian Journal of Pharmaceutical Clinal Research, 6(2), 21-25.
Covarrubias CE, Rivera TA, Soto CA, Deeks T, Kalergis AM. (2022). Current GMP standards for the production of vaccines and antibodies: An overview. Frontiers in Public Health, 10(1), 1-12.
Anshika S, Garima V, Doli Rani D. (2016). Current Good Manufacturing Guidelines For Medicinal Product. Journal of Drug Delivery and Therapeutics, 6(2), 57-61.
Geyer ARC, Sousa VD, Silveira D. (2019). Compliance with good manufacturing practices for medicines in Brazil. Accreditation and Quality Assurance, 24(5), 351-360.
Vugigi, SK, Thoithi, GN, Ogaji, JI, Onuonga SO. (2019). Good Manufacturing Practices in the Kenyan Pharmaceutical Industry and Impact of Facility Upgrading on Domestic and International Sales. The East and Central African Journal of Pharmaceutical Sciences, 22(3), 77–84.
Gouveia BG, Rijo P, Gonçalo TS, Reis CP. (2015). Good manufacturing practices for medicinal products for human use. Journal of Pharmacy and Bioallied Sciences, 7(2), 87-96.
Al-Worafi YM. (2020). Medications Registration and Marketing: Safety-Related Issues. Drug Safety in Developing Countries, 1(1), 21-28.
Stoimenova AH, Kirilov BJ, Gueorguiev SR, Petkova-gueorguieva ES, Ognianov SG. (2020). Good Manufacturing Practice for Medicinal Products in Bulgaria : an Analysis of Regulatory Inspection Findings. Folia Medica, 62(1), 165-171.
Aziza F. (2021). 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(2), 243-248.
Fortner ZA. (2021). Mitigating Third-Party Risks: The Benefits of Extending Quality to the Supply Chain. Pharmaceutical Technology, 45(9), 56-60.
Bolende AIR. (2019). Perlindungan Konsumen Terhadap Peredaran Obat Tradisional Berbahan Kimia Obat Menurut Undang-Undang Nomor 8 Tahun 1999 Tentang Perlindungan Konsumen. Lex Privatum, 7(2), 5-10.
Atouf F. (2017). The Role of Quality Standards for Biomanufacturing Raw Materials. Pharmaceutical Technology, 41(8), 44-46.
Rathore AS, Kumar D, Kateja N. (2018). Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting. Current Opinion in Biotechnology, 53(1), 99-105.
Lepore J, Mahmood T, Hartman R. (2020). Development of a quality risk based tool for the selection of regulatory starting materials for commercial drug substance manufacturing processes. Organic Process Research and Development, 24(11), 2762-2771.
Gondokesumo M, Amir N. (2021). Peran Pengawasan Pemerintah Dan Badan Pengawas Obat Dan Makanan (BPOM) Dalam Peredaran Obat Palsu di Negara Indonesia (Ditinjau dari Undang-Undang Nomor 36 Tahun 2009 dan Peraturan Kepala Badan Pengurus Obat dan Makanan). Perspektif Hukum, 21(2), 91-107.
Bretaudeau L, Tremblais K, Aubrit F, Meichenin M, Arnaud I. (2020). Good Manufacturing Practice (GMP) Compliance for Phage Therapy Medicinal Products. Frontiers in Microbiology, 11(1), 1-7.
Fiori GML, Basso FG, Porto GS. (2022). Cooperation in R&D in the pharmaceutical industry: Technological and clinical trial networks in oncology. Technological Forecasting and Social Change, 176(1), 1-15.