Internship Report for Pharmacy Student http://http://repository.i3l.ac.id:80/handle/123456789/289 2026-01-08T12:59:23Z 2026-01-08T12:59:23Z Zafira, Qastalia http://http://repository.i3l.ac.id:80/handle/123456789/966 2023-12-28T03:45:36Z 2023-12-13T00:00:00Z

Title: Regulation Comparison of Good Manufacturing Practice for Benchmarking Future Regulation in National Agency Drug and Food Control (NADFC) Authors: Zafira, Qastalia Abstract: The release of drugs, narcotics, psychotropics, and precursors to the marketshould be controlled. The manufacturing process and distribution need to be supervised to ensure the safety and the quality of the productthatis going to be marketed. Each country has authority bodiesthat are specifically formed to supervise and control the drug related product before and after itis marketed. Indonesia has Badan Pengawas Obat dan Makanan (BPOM) that released good manufacturing practice (GMP) as a regulation system for the release of drug related products. Growth of the drug industry in Indonesia always occurs, therefore, updates on GMP are occasionally needed. The materials for updates can be obtained by benchmarking more advanced countries as an insight. Additionally, comparison and review are made to manage the insights. As for the results, there are 5 points that differ between Indonesian current GMP and pharmaceutical inspection co-operation scheme (PIC/S) newly revised GMP. Furthermore, specific standards and radioisotope handling requirements need to be added to current Indonesian radiopharmaceutical GMP. Lastly, real-time release testing (RTRT) methods are beneficial methods that can be used to test product quality, however, information and requirements of their usage is still limited.

2023-12-13T00:00:00Z Virlia http://http://repository.i3l.ac.id:80/handle/123456789/964 2023-12-18T03:22:28Z 2023-12-13T00:00:00Z

Title: Antibacterial Activity of 4-Hydroxysattabacin Isolated from the Gut Microbiota Aneurinibacillus Aneurinilyticus Authors: Virlia Abstract: The gut microbiota represents a vast reservoir of bioactive substances with potential implications for human health and disease. This study focused on the identification of a novel metabolite originating from the gut microbiota strain Aneurinibacillus aneurinilyticus and evaluated its antibacterial properties. Advanced analytical techniques such as high-performance liquid chromatography, high-resolution mass spectrometry, liquid chromatography-mass spectrometry, and nuclear magnetic resonance were employed with optimization to isolate and identify the metabolites. Following the successful isolation of the target metabolite, subsequent structural elucidation revealed the structure of 4-Hydroxysattabacin. Disk-diffusion antibacterial assays were conducted against the Bacillus subtilis strain as a representative of Gram-positive bacteria to assess 4-Hydroxysattabacin functional significance. The findings demonstrated a substantial inhibitory effect, suggesting 4-Hydroxysattabacin as a potential novel antibacterial agent. Nevertheless, this research has presented a valuable contribution to the realms of natural product discovery and antibacterial drug development.

2023-12-13T00:00:00Z Mardiva, Vanesha Gabriel http://http://repository.i3l.ac.id:80/handle/123456789/963 2025-11-02T12:09:27Z 2023-12-13T00:00:00Z

Title: Stability Testing Evaluation of Non-Irritant and Sulphate-Free Organic Dog Shampoo Authors: Mardiva, Vanesha Gabriel Abstract: Living together closely with pets, people put an increased value on the appearance of their pets, specifically putting more attention towards the hair and skin of the pets. Thus, the majority of cosmetics for dogs are shampoos. These may be utilized to wash the coat, enhance its structural properties, and as adjuvant treatment for various skin diseases. In order to treat various skin diseases present in dog hair and skin, the use of specially formulated shampoo specifically designed for sensitive skin should be considered. Hence, the formulation of non-irritant and sulphate-free organic shampoo specifically used for dogs was performed. In order to test the formulation, several methods of stability testing which include several evaluations of non-irritant and sulphate-free dog shampoo were performed and assessed. These methods of stability testing consist of cycling stability, centrifugation stability, and thermal stability, while several evaluations of the formulation after cycling stability and thermal stability consist of organoleptic testing, pH testing, viscosity testing, solubility, and spreadability. According to the results obtained, each of the formulated shampoos has its own limitations. F3 is expected to be the best formulation since the pH of the formulated shampoo in cycling stability is in accordance with the criteria, while the pH obtained from thermal stability is in accordance with the criteria, specifically at room temperature at 30 ± 2 oC and oven at 40°C. Furthermore, there is no significant difference between all of the formulated shampoos according to other evaluations.

2023-12-13T00:00:00Z Liu, Queen Saint Monica Vannessa http://http://repository.i3l.ac.id:80/handle/123456789/962 2023-12-18T03:17:08Z 2023-12-13T00:00:00Z

Title: Test Item Control and Project of Quality Control at PT Kalbio Global Medika Authors: Liu, Queen Saint Monica Vannessa Abstract: Quality Control (QC) is part of the quality assurance system and holds a critical activity of ensuring drug products' safety, efficacy, and quality fulfill the requirement. Current Good Manufacturing Practice (cGMP) is a standard regulation enforced by the Food and Drug Administration (FDA) to guarantee product quality and must be followed by all pharmaceutical companies. One of the crucial components of cGMP is the execution of Good Documentation Practices (GDocP) that allow traceability of all activities in the manufacturing process. The cGMP of Indonesia, namely Cara Pembuatan Obat yang Baik (CPOB) guideline describes various forms of documents (e.g. logbook and report) and may exist in paper-based and electronic. Test Item Control (TICO) and Project division utilized Logbook and Google Spreadsheet to ensure the traceability of information related to the sample tested, while the final report known as Quality Control Analysis Report (QAR) was prepared to summarize the result of the test conducted to be shared to the requestor department. An approximately 150 to 170 QARs were successfully generated per week, in which the completion was also indicated by the approval from the QC manager and can be handed over to the related department.

2023-12-13T00:00:00Z