Kurikulum 2024

Kode Mata KuliahFA4131 / 3 SKS
Penyelenggara107 - Sains dan Teknologi Farmasi / SF
KategoriKuliah
Bahasa IndonesiaEnglish
Nama Mata KuliahCara Pembuatan Sediaan Farmasi yang BaikGood Manufacturing Practice
Bahan Kajian
  1. Sistem Manajemen Mutu di Industri Farmasi
  2. Kualifikasi personel
  3. Desain bangunan dan fasilitas
  4. Manajemen peralatan produksi
  5. Proses produksi
  6. Pengawasan mutu
  7. Inpeksi diri serta Penanganan keluhan dan penarikan produk
  8. Dokumentasi
  9. Kualifikasi
  10. CPOTB
  11. CPKB
  1. Quality Management System in the Pharmaceutical Industry
  2. Personnel qualifications
  3. Building and facility design
  4. Production equipment management
  5. Production Process
  6. Quality Control
  7. Self-inspection and Handling of complaints and product recalls
  8. Documentation
  9. Qualification
  10. GMP for traditional medicine
  11. GMP for cosmetics
Capaian Pembelajaran Mata Kuliah (CPMK)
  1. Mampu menguraikan personalia dan kualifikasi yang diperlukan
  2. Mampu menjelaskan kebutuhan ruang dan mendesain tata letak bangunan yang dibutuhkan, serta kualifikasinya
  3. Mampu menetapkan desain peralatan dan menjelaskan rangkaian proses produksi sediaan farmasi dan kualifikasinya
  4. Mampu menyusun mengevaluasi pencatatan, pengelolaan, dan pengendalian dokumen
  5. Mampu menjelaskan perbedaan mendasar persyaratan antara CPOB, CPOTB dan CPKB
  1. Able to outline the necessary personnel and qualifications
  2. Able to explain the design of building and its layout, as well as its qualifications
  3. Able to establish equipment design and explain the series of pharmaceutical preparation production processes and their qualifications
  4. Able to compile and evaluate the recording, management, and control of documents
  5. Able to explain the fundamental differences of GMP for drugs, traditional medicine and cosmetics
Metode PembelajaranKuliah, tugas dan diskusiLecture, assignment, discussion
Modalitas PembelajaranAuditorial, visual, sinkronous, asinkronousVisual, auditorial; synchronous and asynchronous
Jenis NilaiABCDE
Metode PenilaianKuis, tugas, UTS dan UASQuiz, assignment, mid exam, final exam
Catatan Tambahan