Study of Contamination Control in The Pharmaceutical Industry Ethylene Glycol and Diethylene Glycol

Main Article Content

Resmilia Anugrah
Daning Nurhalisa Kairupan
Fadhilah Liyana Putri
Munira Ulfa
Fenryco Pratama

Abstract

Contamination cases in health products are on the rise, mainly due to ethylene glycol and diethylene glycol contaminants, which contribute to the high number of child deaths. Contamination caused by toxic compounds should be controlled and minimized to ensure public safety and security. Therefore, contamination control needs further review. This paper aims to discuss HACCP and GMP procedures for controlling and minimizing contaminants in the pharmaceutical industry, as well as policies and coordination between actors to prevent the recurrence of cases of ethylene glycol and diethylene glycol contamination. The research used the literature study method, with hazing's publication or perish as a search tool. The results of this paper show that in the application of HACCP, there are several critical control points, namely the manufacture of drugs, the removal of materials, screening of raw materials, dry mixing, mixing, and packaging. GMP implements controls on sanitation and hygiene, equipment, self-inspection and supplier approval audits, personnel, training, personal hygiene, and locations and buildings. In order to prevent the recurrence of contamination cases, it is necessary to apply policies related to suppliers of raw materials, raw materials, and the application of GMP. Coordination between actors at the country and company scales is necessary to prevent the recurrence of ethylene glycol and diethylene glycol contamination cases.

Article Details

Section
Articles

References

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.