Course Information
Course Semester Plan
Course Information
| No | Module name | Validation and Regulatory Issues in Industry |
| 1 | Courses code | P20.01019 |
| 2 | Study loads | 2 credits |
| 3 | Semester | First Semester |
| 4 | Precondition | there is no |
| 5 | Competence | Upon completion of this course, students are expected to be able to: 1. List and explain the psychochemical properties of solute and solvent that affect solubility, stability, and other bio pharmaceutical properties in drug dosage forms development. 2. Analyze and interpret data. 3. Develop, validate and apply different instrumental methods to the analysis of medicinal substances in various dosage forms. 4. Characterize and evaluate physicochemical properties of pharmaceutical ingredients. 5. Show contributions in individual or group projects |
| 6 | Elements of competency | MKK |
| 7 | Type competency | Supporting competence |
| 8 | Syllabus | 1. Study contract; 2. Validation of analytical methods; 3. HPLC method validation; 4. Dissolution method validation; 5. Heavy metals limit test; 6. Bioanalytical method validation; 7. Qualification and calibration of analytical instruments; 8. Midterm Examination; 9. Performance verification in UV-Vis Spectroscopy; 10. Performance verification in HPLC; 11. Latest regulations in pharmaceutical industry about labelling; 12. Latest regulations in pharmaceutical industry about halal labelling; 13. Latest regulations in pharmaceutical industry about BABE; 14. Protocol of analytical methods validation;15. BABE protocol; 16. Final Examination |
| 9 | Attribute to soft skills | discipline, ethics |
| 10 | Learning methods | Project-based and Content-Based learning |
| 11 | Learning media | LCD |
| 12 | Appraisal | Answer question individually in multiple choices and essay, presentation and discussions |
| 13 | Lecturer | Apt. Mutakin, M.Si P.hD Dr. Apt. Ida Musfiroh, M.Si, and Dr. Apt. Aliya Nur Hasanah, M.Si |
| 14 | References | Chung Chow Chan, Y.C. Lee, Herman Lam, Xue-Ming Zhang (editors), Analytical Method Validation and Instrument Performance Verification, Wiley-Interscience, 2004. Analytical and Bioanalytical chemistry, 2020, 412 (3) ; 531-532, Bioanalytical method validation : How much should we do and how should we document USP 34, 2011 Analytical Procedures and methods validation for drug and biologics, guidance for industry, US Department of Health and Human Services, FDA, 2015 IOSR Journal of Pharmacy, A review on step by step analytical method validation, volume 5(10), 2015, pp 7-19 FDA, Bioanalytical Method Validation: Guidance for Industry, 2018 Susan R. Mikkelsen, Eduardo Corton, Bioanalytical Chemistry, Wiley Interscience, 2004. Chief regulatory of The National Agency for Drug and Food Control of Indonesia No HK.03.1.23.12.11.10217 year 2010: Bioequivalence Test |
Course Semester Plan