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Eruditio : Indonesia Journal of Food and Drug Safety
Published by Badan Pengawas Obat dan Makanan
ISSN : 27472493     EISSN : 28076222     DOI : https://doi.org/10.54384
Core Subject : Health, Science, Agriculture,
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health
Eruditio : Indonesia Journal of Food and Drug Safety adalah jurnal yang diterbitkan oleh Pusat Pengembangan Sumber Daya Manusia Pengawasan Obat dan Makanan (PPSDM POM), Indonesia. Jurnal ini memuat hasil kajian dan kajian literatur di bidang keamanan Obat dan Makanan.
Arjuna Subject : Pharmacology, Toxicology and Pharmaceutics - Ilmu Farmasi
Articles 65 Documents
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Performance Characteristics of the Quantitative Method for Staphylococcus aureus in Food Products corresponds to ISO 16140-3: 2021 Putri, Fannisa; Surati, Sri; Sitorus, Aditya Anugerah Marusaha; Nagur, Kemala Suardi; Cahyaningsih, Eni; Wilasti, Yulin; Sihotang, Maria Arieni Eka Devina
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.196

Abstract

Good food sanitation is one of the main pillars for achieving food security goals. High levels of Staphylococcus aureus in food can indicate poor hygiene and handling practices during food production, processing, or storage. Before testing, the laboratory needs to verify the quantitative method for Staphylococcus aureus to produce valid data to ensure food safety and quality. The Centre of National Quality Laboratory of Drugs and Food, Indonesian Food and Drug Authority (FDA) has never verified the Staphylococcus aureus quantification method based on the latest ISO 16140-3:2021. Following the guidelines established in ISO 16140-3:2021, method verification is accomplished by calculating the Interlaboratory Reproducibility Standard Deviation (SIR) for implementation validation and the eBias value for verifying the method's suitability for assessing specific food items. This research was conducted to confirm the ISO 6888-1:2021 as the designated reference method for quantifying Staphylococcus aureus in food products. The cheese was utilized as the test food item to verify the implementation of the method. At the same time, several products, including condensed milk, margarine, baby porridge, cassava chips, and ready-to-eat sausage, were examined as challenging food types. Every chosen food item was artificially contaminated with Staphylococcus aureus WDCM 00034. The SIR value obtained was 0.04 ≤ 2× 0.11 (the lowest mean of SR value from ISO 6888-1:2021), which indicated that the Centre of National Quality Laboratory of Drugs and Food Indonesian FDA was able to implement the method very well. In addition, the eBias value for all types of food tested was below 0.5log10, which showed that the quantitative method for coagulase-positive Staphylococci (Staphylococcus aureus and other types) could be applied in the Centre of National Quality Laboratory of Drugs and Food laboratory for the extensive scope of food.
Validasi Metode Deteksi Shigella dalam Tablet Hisap Obat Kuasi Herawati, Desty; Aprianto, Eko; Cahyaningsih, Eni; Miftahurrohmah, Nur
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.199

Abstract

Lozenges, a quasi-drug used to relieve sore throats, must meet the safety and quality requirements according to Indonesian FDA Regulation No. 7 of 2023 concerning the criteria and procedures for quasi-drug registration, which stipulates that oral preparations of quasi-drugs must be free from Shigella spp—microbial contamination. Contamination by Shigella bacteria can cause diseases such as shigellosis, characterized by symptoms such as diarrhoea, vomiting, and fever. This study aims to validate the Shigella spp—detection method in quasi-drug lozenges using the WHO (Quality Control Methods for Herbal Materials) reference method. Validation was carried out to ensure that this method can be used for routine analysis in the Indonesian FDA laboratory. The guidelines used to validate the microbiological method are the Singapore Accreditation Council (SAC) Guidance Notes C&B AND ENV 002 of 2019 and refer to pharmacopoeias. The study results showed that the WHO (Quality Control Methods for Herbal Materials) method in detecting Shigella sp. has a sensitivity and specificity of 100%, with false positive and false negative rates of 0% each. The detection limit obtained was 3 cfu/g, which meets the requirements (below 10 cfu/g). The method suitability test (optimization) showed that the initial solvent used for sample homogenization in Shigella detection was sufficient using Tryptone Soya Broth (1:10) without additional neutralization or modification procedures at the sample homogenization stage. Based on these results, the Shigella spp. The WHO reference (Quality Control Methods for Herbal Materials) detection method is accurate. It can be applied for routine microbial contamination testing analysis in the Food and Drug Supervisory Agency laboratories.
Pengembangan Metode Analisis Penetapan Kadar Deksklorfeniramin Maleat Sediaan Tablet Secara Kromatografi Cair Kinerja Tinggi Detektor UV Budiati, Lilik; Ilmiyati, Nurul
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.203

Abstract

Dexchlorpheniramine maleate, an antihistamine for allergy treatment, is traditionally tested in tablet form using the UV spectrophotometric method referenced in United States Pharmacopeia (USP), NF 43. However, this method struggles to separate the active compound from other tablet components, such as dyes, necessitating an extraction process. Extraction has several drawbacks, including high waste production, extensive use of costly pure solvents, prolonged preparation times, and reliance on hazardous volatile solvents. This study aims to develop a safer, more efficient, and effective method using high-performance liquid chromatography (HPLC), modified from the USP, NF 43 standard. The experimental approach involves method development and validation, focusing on selectivity, precision, accuracy, linearity, and robustness. The selectivity test demonstrated a resolution value 19.6 between dexchlorpheniramine and maleic acid peaks. The specificity test confirmed identical retention times and spectra between standard and sample peaks. Precision testing yielded a relative standard deviation (RSD) below 0.37%. Accuracy tests at 80%, 100%, and 120% levels achieved an average recovery of 99% within the 97%–103% acceptance range. Linearity testing resulted in a correlation coefficient (r) 1.00 and Vx0 of 0.1. ANOVA test results on Robustness testing revealed no significant differences with column modification but identified sensitivity to pH and mobile phase composition changes. In conclusion, the developed HPLC method meets validation parameters, providing a reliable alternative for analyzing dexchlorpheniramine maleate tablets, with attention to pH and mobile phase suitability.
Audit Komunikasi Program Intervensi Keamanan Pangan Jajanan Anak Sekolah Balai Besar Pengawas Obat dan Makanan di Yogyakarta Wulandari, Wulandari; Suparno, Basuki Agus; Prayudi, Prayudi
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.206

Abstract

Unsafe school children's snacks (PJAS) pose health risks and can cause various diseases. To address this, the PJAS Safety Intervention Program was introduced. The COVID-19 pandemic brought changes to the definition of PJAS and altered communication patterns in program delivery. This study evaluates the success of the program implemented by the Indonesian Food and Drug Authority Regional Office in Yogyakarta during the pandemic. It identifies factors inhibiting its effectiveness through a communication audit. The research used an evaluative qualitative method involving interviews with informants to assess planning and preparation and surveys with school community respondents to evaluate program communication. The study followed the General Guidelines for Communication Audits in Government Agencies. Results indicate that the program was effectively implemented and can be enhanced by improving communication dimensions. Key strategies include strengthening message delivery through direct engagement with policymakers, expanding media use by adding hardcopy materials, improving message clarity with comprehensive posters detailing program stages, and fostering public feedback through information sharing and participation mechanisms, particularly at junior and senior high school levels. Additionally, expanding promotional media can further optimize program outreach. The communication audit concluded that the PJAS Safety Intervention Program successfully met its objectives through effective management with minor, manageable obstacles. These findings suggest that the program can continue with improved communication strategies to enhance its impact.
Analisis Hasil Pengawasan Iklan Produk Pangan Olahan di Provinsi DKI Jakarta pada tahun 2021-2023 Saifudin, Umar; Noviardani, Tenri
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.208

Abstract

Food is a fundamental need in society, and advertising significantly influences the consumption of processed food products. Advertising introduces products for businesses and provides product-related information for consumers. However, some advertisements violate regulations. Supervising processed food advertisements is one of the Indonesian Food and Drug Authority's (FDA) roles. This study analyzes processed food advertisement supervision in DKI Jakarta from 2021 to 2023, focusing on media types, violation types, and food categories most frequently violating regulations. Secondary data from supervision reports collected by the Jakarta FDA Office during this period were analyzed descriptively. Results show that 1468 (77.7%) of the 1890 advertisements evaluated did not meet regulatory requirements. Most violations occurred in online media (1424 ads, 97%), followed by outdoor media (39 ads, 2.7%) and print media (5 ads, 0.3%). The most common violations included health claims not complying with provisions (1110 ads, 75.7%), misleading advertisements (175 ads, 11.9%), prohibited advertising in non-health media (160 ads, 10.9%), superlative statements (21 ads, 1.4%), and norm violations (1 ad, 0.1%). Violations based on food categories were highest in beverages (category 14) with 1149 ads (78.3%), milk products (category 1) with 66 ads (4.5%), and sugar products and sweeteners (category 11) with 49 ads (3.3%). These findings highlight the need for stricter oversight and public awareness of advertising regulations.
Development and Validation of a Method for Detecting and Quantifying Mitragynine in Kratom Samples Using HPLC-PDA Isnaeni, Neni; Saefumillah, Asep; Cahyana , Antonius Herry
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.209

Abstract

Kratom (Mitragyna speciosa Korth) has been identified as a New Psychoactive Substance (NPS) by the United Nations Office on Drugs and Crime (UNODC) and included in the list of prohibited ingredients in food supplements and traditional medicine by Indonesian FDA. Therefore, a rapid, easy, and reliable analytical method is necessary to detect and quantify this plant and its products. This study developed a method for the detection and quantification of kratom products based on a unique compound, mitragynine, as a biomarker. A previous survey of determining mitragynine in Kratom using GC-MS, LC-MS/MS, UPLC, and HPLC-PDA. Previously, the HPLC-PDA method used a C8 column. Yet, for efficiency, it is also necessary to develop a test method using a C18 column. Analysis was performed using an HPLC - PDA system with Waters Atlantis T3-C18 (250 x 4.6 mm, 5 µm) column. The mobile phase comprises acetonitrile and formic acid 0.05%, pH 5.0 (75:25 v/v), delivered at a 1.0 mL/min flow rate. Detection was carried out at a wavelength of 225 nm. The analytical method was validated with test parameters of selectivity, system suitability, accuracy, precision, linearity, detection limit, and quantification limit. The validation study demonstrated an excellent linear concentration range of 1.96 - 6.01 µg/mL with a correlation coefficient of 0.9996; the detection limit is 0.14 µg/mL, while the limit of quantification is 0.45 µg/mL—accuracy method of 98.88 - 101.44% and a bias of 0.27%. The percent relative standard deviation for six independent assay determinations was 0.67%, and the intermediate precision was 1.56% on two days. The mitragynine amounts in these materials ranged from 6.01 to 6.31 mg/g of dried leaf material. Based on the research results, it can be concluded that the method developed provides quick, simple, reliable, accurate, and valid, and has an advantage over existing methods in terms of simplicity of sample preparation, short analysis time, and cost-effectiveness compared to GCMS and LCMS/MS and can be applied for future analysis in Kratom samples.
Engagement Masyarakat Atas Format Akun Media Sosial Instagram BPOM di Ambon Tahun 2023 Agusta, Mohammad Viva; Santoso, Nugroho Budi
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.213

Abstract

Public awareness regarding the importance of safe drugs and food is crucial. However, products still have the potential to be unsafe, so the community needs to be equipped with knowledge through Information, Education, and Communication (IEC). Due to advances in information technology and the increasing number of internet users, IEC can be conducted through electronic and social media to reach a wider audience. Instagram is one of the platforms used by the Indonesian Food and Drug Authority (Indonesian FDA) Regional Office in Ambon for IEC. It has the potential to serve as a medium for communicating, disseminating information, and educating the public about safe drugs and food. However, an analysis of Instagram user engagement with the content created is needed. This study aims to determine Instagram user engagement with content formats on the Indonesian FDA Regional Office in Ambon. Instagram account using quantitative research methods with a descriptive approach. The research-dependent variable is the content format (video, photo, infographic), and the independent variable is engagement (like, comment, save, share). Engagement analysis was conducted on 509 posts during 2023, consisting of 51 (10.02%) video content, 174 (34.19%) photos, and 284 (55.80%) infographics. The results of the analysis show that photo content formats have higher engagement than videos and infographics, with an average number of likes (25.03), saves (0.29), and shares (0.69). Meanwhile, video content formats have a higher average number of comments (0.14) compared to photos and infographics. This study concludes that photo and video content have higher engagement, so it can be chosen as priority content to increase follower engagement on the Indonesian FDA Regional Office in Ambon Instagram account.
Kajian Kepatuhan Sarana Produksi Minyak Goreng Sawit di Wilayah Kerja BBPOM di Bandung dan BBPOM di Surabaya dalam Melakukan Fortifikasi Vitamin A Utami, Setyo; Andriany , Dinny
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.214

Abstract

Vitamin A deficiency (VAD) remains a public health issue in many countries, including Indonesia. To address this, the government has mandated vitamin A fortification in food, with cooking oil being a key target. The policy is outlined in SNI 7709-2019 through Minister of Industry Regulation Number 46 of 2019, requiring producers to achieve a minimum vitamin A level of 45 IU/g in fortified cooking oil. Samples of palm cooking oil were collected from producers and packers for evaluation. This study examines the compliance of palm cooking oil production facilities within the Bandung and Surabaya catchment areas under the supervision of THE INDONESIAN FDA REGIONAL OFFICE. Using a descriptive qualitative method, data were collected from sampling and testing conducted between 2021 and 2023, following the Guidelines for Sampling and Testing of Drugs and Food. The results indicate that 31.58% of production facilities failed to meet fortification requirements due to a lack of commitment from producers and limited availability of vitamin A as a fortifier. Non-compliance was linked to facility type, with relaxation of regulations during rising cooking oil prices contributing to the issue. Notably, the fortification program was temporarily paused in January 2022 due to these challenges. To ensure public health benefits, it is essential to reinstate and enforce the vitamin A fortification program for palm cooking oil, emphasizing producer accountability and stable raw material supply.
Analisis Efektivitas Program Pangan Jajanan Anak Sekolah Aman dalam Perubahan Pengetahuan, Sikap, Perilaku Anak Sekolah di Sulawesi Tenggara Idrus, Dewi Amni; Agustina, Dian Reni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 4 No 2 (2024): June Edition
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v4i2.217

Abstract

Snacks are trendy foods with school-age children to fulfil their energy and nutrition needs in the school environment and must be ensured to be safe from biological, chemical, and physical contamination. However, food safety of school snacks program (PJAS) in Indonesia is still a reasonably concerning problem. One of the efforts made by the government to protect school-age children from unsafe PJAS is by increasing the knowledge, behavior, and attitudes of school children in choosing, buying, and consuming food through the Safe PJAS Program. This study aimed to examine the effect of the Safe PJAS program on the knowledge, attitudes, and behavior of school children in Southeast Sulawesi and the effectiveness of the Safe PJAS program in terms of the Knowledge, Attitudes, and Behavior of school children. The research methodology used was the quantitative analysis with Wilcoxon Test and Oneway Anova Test and literature review. The research results showed it was found that the Safe PJAS program carried out in Southeast Sulawesi in 2023 in Wakatobi and Central Buton Regencies had an impact and was influential in increasing the knowledge, attitudes, and behavior of school children in choosing and consuming snack foods. The author's recommendation for the Safe PJAS Program is that the Indonesian FDA can improve coordination and communication with the Ministry of Education and Culture to include food safety material in the independent learning curriculum and increase advocacy to obtain support from the Regional Government in allocating a budget for improving canteen facilities and infrastructure and to replicate the Safe PJAS program.
Pendekatan Tipologi Tonry-Farrington dalam Upaya Pencegahan Peredaran Produk Pangan Olahan Ilegal di Wilayah Perbatasan Negara Indonesia Yovia, Rizki Arrahman; Wibowo, Andi
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.169

Abstract

The circulation of processed food, particularly imported unregistered products (TIE), is a significant contributor to crime vulnerability in border areas, accounting for 71% of total findings. This has become a complex issue due to its close links with the socio-economic conditions of local communities. A purely repressive approach has proven insufficient for comprehensive mitigation of this phenomenon. This study employed a mixed-methods approach, combining quantitative and qualitative methods, to examine and explain community and institutional participation, including law enforcement agencies, in addressing crime vulnerability related to processed food commodities in Indonesia’s border regions, based on the Tonry-Farrington typology. The study area covers North Kalimantan, West Kalimantan, Riau, Riau Islands, and East Nusa Tenggara provinces. The findings indicate that crime prevention using the Tonry-Farrington typology can be implemented through: (1) Developmental and Social Prevention, emphasizing crime prevention functions by engaging local key opinion leaders and traditional authorities with reputable standing to support BPOM’s efforts; (2) Community-Based Prevention, promoting collaborative approaches and resource-sharing to enhance value creation; (3) Situational Prevention, involving joint supervision and collaboration with well-informed stakeholders; and (4) Law Enforcement, advocating collaborative measures with the criminal justice system to establish strong legitimacy and a deterrent effect on offenders. The Tonry-Farrington typology can be adapted by BPOM as a novel approach to address the circulation of TIE food products in Indonesia’s border regions, enabling holistic and integrated management of crime vulnerability in these areas.

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