EAG608 - GOOD LABORATORY PRACTICE and METHOD VALIDATION
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| GOOD LABORATORY PRACTICE and METHOD VALIDATION | EAG608 | Any Semester/Year | 2 | 0 | 2 | 5 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Problem Solving | |||||
| Instructor (s) | Prof.Dr. Nursabah Başçı, Prof.Dr. Emirhan Nemutlu | |||||
| Course objective | To gain knowledge about the good laboratory practice (GLP) applications and analytical method validation which are used mandatorily in drug industry quality control laboratories | |||||
| Learning outcomes |
| |||||
| Course Content | Principles and current concepts for good laboratory practice (GLP) and analytical method validation applications in drug industry quality control laboratories. | |||||
| References | 1. Good Laboratory Practice (GLP): quality practices for regulated non-clinical research and development, 2nd ed. World Health Organisation, 2009 2. Guidance for Industry, Bioanalytical Method Validation, Food and Drug Administration 2013 Revision 1 3. ICH, 2006 4. Ermer J., Validation in pharmaceutical analysis. Part I: an integrated approach, J Pharm Biomed Anal. 2001 Mar;24(5-6):755-67. 5. OTHER RELATED RECENT GUIDES, PAPERS AND BOOKS | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Good Laboratory Practice (GLP) and basic principles |
| Week 2 | GLP and related regulations |
| Week 3 | Test item organisation and job descriptions, management of quality assurance |
| Week 4 | Planning of GLP studies, development of standard study methods, reporting of results Records, materials, handling and disposal of wastes |
| Week 5 | Calibration and qualification of equipments |
| Week 6 | Test systems, reference standards and materials |
| Week 7 | GLP and investigations |
| Week 8 | Midterm exam |
| Week 9 | Method validation strategies according to different guides |
| Week 10 | Method validation parameters: Specificity, range, linearity |
| Week 11 | Method validation parameters: Accuracy, precision, ruggedness, robustness |
| Week 12 | System suitability parameters and evaluation |
| Week 13 | Reporting of method validation results |
| Week 14 | Examination of validation parameters in drug and dissolution analysis |
| Week 15 | Method transfer and revalidation |
| Week 16 | Final exam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 1 | 50 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 50 |
| Percentage of final exam contributing grade succes | 1 | 50 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 2 | 28 |
| Laboratory | 0 | 0 | 0 |
| Application | 4 | 2 | 8 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 6 | 5 | 30 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 1 | 10 | 10 |
| Midterms (Study duration) | 1 | 24 | 24 |
| Final Exam (Study duration) | 1 | 5 | 5 |
| Total Workload | 27 | 48 | 105 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has knowledge in the area of preformulation and formulation designs about industrial production, quality control, quality assurance system and stability | X | ||||
| 2. Acquires information about nanotechnology, new drug delivery systems and controlled release systems | |||||
| 3. Learns to keep track of up to date literature and patents using the knowledge and informatics technologies | X | ||||
| 4. Interprets the guidelines of health authorities such as FDA, EMA and international guidelines such as GMP, ANDA, BA/BE, QA/QC, acquires application knowledge and skills | X | ||||
| 5. Has knowledge to understand and interpret chemical, instrumental and pharmacological data | |||||
| 6. Has basic concepts about medicinal chemistry such as design of new drug molecules, drug-receptor interactions | |||||
| 7. Has the knowledge on the rules of scientific ethics which should be complied | X | ||||
| 8. Effectively uses the conventional and new synthetic methods. | |||||
| 9. Has knowledge of advanced toxicity tests accepted by regulatory authorities | |||||
| 10. Has knowledge about pharmacological experimental methods and their applications used in drug research and evaluates analysis results | |||||
| 11. Has knowledge about preclinical and clinical drug research | |||||
| 12. Has knowledge about the pharmacokinetic and pharmacodynamic properties of drugs | |||||
| 13. Has knowledge about the pharmacokinetics and pharmacodynamics of drugs | X | ||||
| 14. Has knowledge of and the ability to use the devices and instruments used in the application of instrumental analysis methods | X | ||||
| 15. Has the ability to apply theoretical and practical knowledge in the analysis of substances in medicinal products and biological materials | X | ||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest