Course Information
Course Semester Plan
Course Information
| No | Module Name | Industrial Pharmacy |
| 1 | Code of Subjects | P12A.0107 |
| 2 | Study Load | 2 Credits |
| 3 | Semester | I |
| 4 | Precondition | There is no |
| 5 | Competence | students are able to: Design product development until the scale up stage, Design procedures and analysis methods of the product, – Determine the factors and production parameters of a product, including its GMP, – Define the registration path that a product must follow, |
| 6 | Element of Competency | Main Competency |
| 7 | Type Competency | MKK |
| 8 | Course syllabus is about : | |
1. Product development: • Preformulation • Formulation • determination of packaging • Stability test 2. Quality Control • Determination of analysis methods • Validation of analytical methods 3. Stability test 4. Scale up 5. Machinery and equipment 6. Building and facilities. 7. Quality Control 8. Production Planning and Inventory Control 9. Support System (utility) 10. Production 11. Safety, Health, Enviroment Management 12. Pharmaceutical Product Registration |
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| 9 | Attribute Soft Skill | Critical and analytical thinking |
| 10 | Learning Methods | Case study and self-directed learning, Lecture and Role Play Simulation, Collaborative learning and cooperative learning |
| 11 | Learning Media | LCD |
| 12 | Appraisal | Quiz 20%; Mid Assesment 30%; Final Assesment 30%; Soft Skill 20% |
| 13 | Lecturer | Dr. rer. nat. Anis Yohana Chaerunisaa; Drs., apt. Basuki Hadi, MM; apt. Damaris Hutapea, M.Si.; Dr. Ida Musfiroh, M.Si.,Apt. |
| 14 | References Required : | |
| Indonesian Pharmacopoeia V Year 2014 CPOB 2018 CPOB Annex 2018 Adejare, A. (2020) Remington: The Science and Practice of Pharmacy, Edition 23, Academic Press, ISBN 9780128223895 Aulton, M., Taylor, K. (2021), Aulton’s Pharmaceutics, The Design and Manufacture of Medicines, 6th Edition, Elsevier. Paperback ISBN: 9780702081545 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 The United States Pharmacopeia – the National Formulary 2019 : USP 42 – National Formulary 37 Prof. Fabio De Felice et al., (2013), “Operations Management,” Open Educational Resource (OER) Annex 6 WHO good manufacturing practices for sterile pharmaceutical products, WHO Technical Report Series, No. 961, 2011 Modules Teacher Slides Tutorial video |
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Course Semester Plan