| Kode Mata Kuliah | FD5015 / 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 | Pengembangan dan Validasi Unit Proses di Industri Farmasi | Development and Validation of Process Unit in the Pharmaceutical Industry |
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| Bahan Kajian | - Dasar unit proses
- Proses dalam manufaktur farmasi dan QBD
- Process Analytical Technology
- Peran laboratorium analisis dalam pengembangan produk dan sistem manajemen mutu laboratorium
- Metode analisis kompendial dan statistik dalam metode analisis
- Pengembangan metode analisis dan kualifikasi peralatan laboratorium
- Validasi metode analisis dan siklus kesinambungan status validasi
| - Basics of process unit
- Manufacturing process and QBD
- Process Analytical Technology
- The role of analytical laboratories in product development and laboratory quality management system
- Compendial analytical methods and statistic in analytical methods
- Development of analytical methods and qualification of laboratory equipment
- Validation of analytical methods and validation status continuity cycle
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| Capaian Pembelajaran Mata Kuliah (CPMK) | - Mampu menjelaskan berbagai unit proses terkait di industri farmasi serta memanfaatkan peran laboratorium analisis dalam pengembangan produk dan sistem manajemen mutu laboratorium dengan menggunakan ilmu dan teknologi kefarmasian terbaru
- Mampu menjelaskan metode analisis kompendial dan penerapan statistik dalam metode analisis sesuai dengan standar cara pembuatan obat yang baik (CPOB) di industri farmasi
- Mampu menerapkan regulasi yang berkaitan dengan industri farmasi melalui pengembangan metode analisis dan kualifikasi peralatan laboratorium
- Mampu mengidentifikasi dan menyelesaikan permasalahan di industri farmasi secara menyeluruh dengan melakukan validasi metode analisis dan menjaga siklus kesinambungan status validasi
- Mampu merancang proses komersialisasi hasil penelitian di industri farmasi dengan mengembangkan metode analisis yang efektif dan efisien
| - Able to explain various processing unit in pharmaceutical industry and utilize the role of analytical laboratories in product development and laboratory quality management systems using state of the art in pharmacy
- Able to explain the compendial analytical methods and the application of statistics in the analytical method in accordance with the cGMP in the pharmaceutical industry
- Able to implement regulations related to the pharmaceutical industry through the development of analytical methods and qualification of laboratory equipment
- Able to identify and solve problems in the pharmaceutical industry comprehensively by validating analytical methods and maintaining the validation status continuity cycle
- Able to design the process of commercialization of research results in the pharmaceutical industry by developing effective and efficient analytical methods
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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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