Course Information
Course Semester Plan
Course Information
| No | Module Name | Quality Assurance |
| 1 | Code of Subjects | P12A.0108 |
| 2 | Study Load | 2 Credits |
| 3 | Semester | I |
| 4 | Precondition | There is no |
| 5 | Competence | After attending this course, students master the theory and theory and the application of certain fields of knowledge and skills in quality assurance of a desired product. |
| 6 | Element of Competency | MKK |
| 7 | Type Competency | Main Competency |
| 8 | Course syllabus is about : | |
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1. Concept of quality, quality assurance, quality management 2. Personnel training 3. Documentation 4. Sampling 5. Validation 6. Batch failure / deviation investigation; complaint handling 7. Vendor Evaluation 8. Risk Management 9. Change Control 10. Management Reviews |
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| 9 | Attribute Soft Skill | Critical and analytical thinking |
| 10 | Learning Methods | Lecture Cooperative Learning, Role Play, Case study, Simulation, Collaborative learning |
| 11 | Learning Media | LCD |
| 12 | Appraisal |
Quiz 20%; Mid Assesment 30%; Final Assesment 30%; Soft Skill 20% |
| 13 | Lecturer | Prof. apt. Muchtaridi, Ph.D; Drs. Apt. Ariyono Ardi, MM; Drs. Apt. Basuki Hadi, MM. |
| 14 | References Required : | |
| Indonesian Pharmacopoeia V Year 2014 CPOB 2018 CPOB Annex Adejare, A. (2020) Remington: The Science and Practice of Pharmacy, Edition 23, Academic Press, ISBN 978012822389 Niazi, S.K. (2019). Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products (1st ed.). CRC Press. https://doi.org/10.1201/9781315103389 Niazi, S.K. (2019). Handbook of Pharmaceutical Manufacturing Formulations: Semisolid Products (3rd ed.). CRC Press. https://doi.org/10.1201/9781315102856 Niazi, S.K. (2019). Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Liquid Products (3rd ed.). CRC Press. https://doi.org/10.1201/9781315102917 Guidelines/ cGMP Akers, M.J. (2010). Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality (1st ed.). CRC Press.https://doi.org/10.3109/9781420020564 Questions & Answers Implementation of GMP Guidelines 2018 ICH guidelines (Guidance for Industry Q2B Validation of Analytical Procedures: Methodology VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2(R1) ) |
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Course Semester Plan