| Kode Mata Kuliah | FD5016 / 3 SKS |
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| Penyelenggara | 218 - Farmasi Industri / SF |
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| Kategori | Kuliah |
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| Bahasa Indonesia | English |
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| Nama Mata Kuliah | Jaminan & Pengawasan Mutu Produk Farmasi | Quality Assurance & Control of Pharmaceutical Products |
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| Bahan Kajian | - Pendahuluan, sistem manajemen mutu, dan sistem penjaminan mutu
- Kasus-kasus kontaminasi dan impurities kimiawi dalam Active Pharmaceutical Ingredients (API) maupun Pharmaceutical Excipients (PE) dan mitigasi risikonya
- Metode analisis terkini untuk identifikasi dan kuantifikasi kontaminasi dan impurities kimiawi dalam pada kadar rendah dan matriks kompleks
- Kualifikasi dan validasi peralatan, kontrol spesifikasi pengguna, serta analisis kapabilitas proses
- Manajemen risiko mutu, teknologi analisis proses, studi kasus QbD, dan lean six sigma
| - Introduction, quality management system, and quality assurance system
- Cases of contamination and chemical impurities in Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Excipients (PE) and their risk mitigation
- State-of-the-art analytical methods for the identification and quantification of contaminant and chemical impurities at low levels and complex matrices
- Equipment qualification and validation, user specification control, and process capability analysis.
- Quality risk management, process analytical technology, QbD case studies, and lean six sigma.
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| Capaian Pembelajaran Mata Kuliah (CPMK) | - Mampu menerapkan ilmu dan teknologi kefarmasian terkini dalam pengembangan metode analisis yang relevan di industri farmasi
- Mampu menjelaskan kasus-kasus kontaminasi dan impurities kimiawi dalam Active Pharmaceutical Ingredients (API) maupun Pharmaceutical Excipients (PE) dan berperan serta dalam mitigasi risikonya
- Mampu mendeskripsikan secara komprehensif penerapan Cara Pembuatan Obat yang Baik (CPOB) di industri farmasi
- Mampu mengimplementasikan berbagai regulasi yang berlaku di industri farmasi
- Mampu menerapkan sistem manajemen yang efektif dan efisien dalam seluruh proses bisnis di industri farmasi
- Mampu mengidentifikasi permasalahan yang muncul di industri farmasi dan memberikan solusi yang komprehensif
- Mampu merancang proses komersialisasi hasil penelitian di industri farmasi
| - Able to apply the state-of-the-art pharmaceutical science and technology in the development of relevant analytical methods in the pharmaceutical industry
- Able to explain cases of contamination and chemical impurities in Active Pharmaceutical Ingredients (API) and Pharmaceutical Excipients (PE) and participate in risk mitigation
- Able to comprehensively describe the application of cGMP in the pharmaceutical industry
- Able to implement various regulations in the pharmaceutical industry
- Able to implement an effective and efficient management system in all business processes in the pharmaceutical industry
- Able to identify problems that arise in the pharmaceutical industry and provide comprehensive solutions
- Able to design the commercialization process of research results in the pharmaceutical industry
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| Metode Pembelajaran | Kuliah, diskusi, belajar mandiri, presentasi | Lecture, discussion, independent study, presentation |
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| Modalitas Pembelajaran | Visual, auditorial, sinkronous, asinkronous | Visual, Auditorial, Synchronous, Asynchronous |
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| Jenis Nilai | ABCDE |
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| Metode Penilaian | Ujian tertulis, karya tulis, presentasi | Written exam, article/report, presentation |
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| Catatan Tambahan | | |
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