| Kode Mata Kuliah | FA4131 / 3 SKS |
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| Penyelenggara | 107 - Pharmaceutical Science and Technology / SF |
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| Kategori | Lecture |
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| Bahasa Indonesia | English |
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| Nama Mata Kuliah | Cara Pembuatan Sediaan Farmasi yang Baik | Good Manufacturing Practice |
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| Bahan Kajian | - Sistem Manajemen Mutu di Industri Farmasi
- Kualifikasi personel
- Desain bangunan dan fasilitas
- Manajemen peralatan produksi
- Proses produksi
- Pengawasan mutu
- Inpeksi diri serta Penanganan keluhan dan penarikan produk
- Dokumentasi
- Kualifikasi
- CPOTB
- CPKB
| - Quality Management System in the Pharmaceutical Industry
- Personnel qualifications
- Building and facility design
- Production equipment management
- Production Process
- Quality Control
- Self-inspection and Handling of complaints and product recalls
- Documentation
- Qualification
- GMP for traditional medicine
- GMP for cosmetics
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| Capaian Pembelajaran Mata Kuliah (CPMK) | - Mampu menguraikan personalia dan kualifikasi yang diperlukan
- Mampu menjelaskan kebutuhan ruang dan mendesain tata letak bangunan yang dibutuhkan, serta kualifikasinya
- Mampu menetapkan desain peralatan dan menjelaskan rangkaian proses produksi sediaan farmasi dan kualifikasinya
- Mampu menyusun mengevaluasi pencatatan, pengelolaan, dan pengendalian dokumen
- Mampu menjelaskan perbedaan mendasar persyaratan antara CPOB, CPOTB dan CPKB
| - Able to outline the necessary personnel and qualifications
- Able to explain the design of building and its layout, as well as its qualifications
- Able to establish equipment design and explain the series of pharmaceutical preparation production processes and their qualifications
- Able to compile and evaluate the recording, management, and control of documents
- Able to explain the fundamental differences of GMP for drugs, traditional medicine and cosmetics
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| Metode Pembelajaran | Kuliah, tugas dan diskusi | Lecture, assignment, discussion |
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| Modalitas Pembelajaran | Auditorial, visual, sinkronous, asinkronous | Visual, auditorial; synchronous and asynchronous |
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| Jenis Nilai | ABCDE |
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| Metode Penilaian | Kuis, tugas, UTS dan UAS | Quiz, assignment, mid exam, final exam |
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| Catatan Tambahan | | |
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