Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| INDUSTRIAL PHARMACY | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Assoc.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assoc.Prof. Muhammet Davut ARPA |
| Assistant(s) | |
| Aim | With the light of pharmacy and engineering information, to explicate the knowledge of sector of the pharmacist who is the most important cornerstone of the pharmaceutical industry and to inform the students. |
| Course Content | This course contains; 1. Basic Operations in the Pharmaceutical Industry,2. Electrotechnical/ Mechatronic,3. Qualification / Validation (including computerized systems),4. HVAC systems, clean room design, WFI systems,5. Pharmaceutical Industry Process and Analytical Technology (PAT),6. Pharmaceutical Industry Process and Analytical Technology (PAT),7. QbD (Quality by Design),8. Examples for QbD and PAT,9. Examples for QbD and PAT,10. Packaging techniques and Technologies.,11. Approach in terms of engineering in Pharmaceutical Analysis,12. Hygiene and sanitation in pharmaceutical industry.,13. Quality management and systems,14. EMEA, FDA and ICH actual guideline. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. defined the basic processes in the pharmaceutical industry. | 12, 14, 17, 9 | A |
| 1.1. list the basic processes in the pharmaceutical industry. | 12, 14, 9 | A |
| 1.2. recognize the equipment used the basic process in the pharmaceutical industries. | 14, 16, 17, 2, 9 | A |
| 2. evaluated qualification and validation | 10, 12, 14, 16, 17, 19, 2 | A |
| 2.1. define qualification and validation. | 14, 5, 9 | A |
| 2.2. categorize qualification. | 12, 14, 17, 9 | A |
| 2.3. identify the requirement of qualification and validation. | 10, 19, 9 | A |
| 3. interpreted PAT, QbD . | 12, 16, 9 | A |
| 3.1. define PAT and QbD. | 9 | A |
| 3.2. interpret the process and analytical technologies in the pharmaceutical industry. | 16, 9 | A |
| 3.3. tell the advantages of QbD in the pharmaceutical industry. | 10, 19, 9 | A |
| 4. distinguished the packaging technologies. | 9 | A |
| 4.1. explain the packaging methods. | 9 | A |
| 4.2. tell the specialities of the packaging technologies. | 9 | A |
| 5. defined the concept about quality assurance. | 10, 12, 14, 16, 9 | A |
| 5.1. define the quality of drug. | 9 | A |
| 5.2. categorize quality assurance. | 10, 16, 19, 9 | A |
| 6. interpreted the current guidelines and legislation of ICH, EMEA, FDA. | 14, 9 | A |
| 6.1. explain the new guidelines of ICH | 9 | A |
| 6.2. define the mission of FDA, EMEA | 9 | A |
| 6.3. assess the guidelines and legislation of ICH, EMEA, FDA. | 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 5: Cooperative Learning, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Basic Operations in the Pharmaceutical Industry | 1,2,3,4 |
| 2 | 2. Electrotechnical/ Mechatronic | 1,2,3,4 |
| 3 | 3. Qualification / Validation (including computerized systems) | 1,2,3,4 |
| 4 | 4. HVAC systems, clean room design, WFI systems | 1,2,3,4 |
| 5 | 5. Pharmaceutical Industry Process and Analytical Technology (PAT) | 1,2,3,4 |
| 6 | 6. Pharmaceutical Industry Process and Analytical Technology (PAT) | 1,2,3,4 |
| 7 | 7. QbD (Quality by Design) | 1,2,3,4 |
| 8 | 8. Examples for QbD and PAT | 1,2,3,4 |
| 9 | 9. Examples for QbD and PAT | 1,2,3,4 |
| 10 | 10. Packaging techniques and Technologies. | 1,2,3,4 |
| 11 | 11. Approach in terms of engineering in Pharmaceutical Analysis | 1,2,3,4 |
| 12 | 12. Hygiene and sanitation in pharmaceutical industry. | 1,2,3,4 |
| 13 | 13. Quality management and systems | 1,2,3,4 |
| 14 | 14. EMEA, FDA and ICH actual guideline | 1,2,3,4 |
| Resources |
| 1-The course notes will be given to the students. |
| 2- Pharmaceutical Engineering, K Sambamurthy, 2007 3- Pharmaceutical Process Engineering, AJ Hickey, D Gonderton, 2001 4- Pharmaceutical Production: An Engineering Guide, B Bennett, G Cole, 2003 |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | ||||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | ||||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | ||||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | ||||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | ||||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 2 | 28 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| Resolution of Homework Problems and Submission as a Report | 1 | 6 | 6 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 2 | 10 | 20 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 1 | 8 | 8 | |||
| General Exam | 1 | 16 | 16 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 78 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(78/30) | 3 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| INDUSTRIAL PHARMACY | - | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Elective |
| Course Coordinator | Assoc.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assoc.Prof. Muhammet Davut ARPA |
| Assistant(s) | |
| Aim | With the light of pharmacy and engineering information, to explicate the knowledge of sector of the pharmacist who is the most important cornerstone of the pharmaceutical industry and to inform the students. |
| Course Content | This course contains; 1. Basic Operations in the Pharmaceutical Industry,2. Electrotechnical/ Mechatronic,3. Qualification / Validation (including computerized systems),4. HVAC systems, clean room design, WFI systems,5. Pharmaceutical Industry Process and Analytical Technology (PAT),6. Pharmaceutical Industry Process and Analytical Technology (PAT),7. QbD (Quality by Design),8. Examples for QbD and PAT,9. Examples for QbD and PAT,10. Packaging techniques and Technologies.,11. Approach in terms of engineering in Pharmaceutical Analysis,12. Hygiene and sanitation in pharmaceutical industry.,13. Quality management and systems,14. EMEA, FDA and ICH actual guideline. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| 1. defined the basic processes in the pharmaceutical industry. | 12, 14, 17, 9 | A |
| 1.1. list the basic processes in the pharmaceutical industry. | 12, 14, 9 | A |
| 1.2. recognize the equipment used the basic process in the pharmaceutical industries. | 14, 16, 17, 2, 9 | A |
| 2. evaluated qualification and validation | 10, 12, 14, 16, 17, 19, 2 | A |
| 2.1. define qualification and validation. | 14, 5, 9 | A |
| 2.2. categorize qualification. | 12, 14, 17, 9 | A |
| 2.3. identify the requirement of qualification and validation. | 10, 19, 9 | A |
| 3. interpreted PAT, QbD . | 12, 16, 9 | A |
| 3.1. define PAT and QbD. | 9 | A |
| 3.2. interpret the process and analytical technologies in the pharmaceutical industry. | 16, 9 | A |
| 3.3. tell the advantages of QbD in the pharmaceutical industry. | 10, 19, 9 | A |
| 4. distinguished the packaging technologies. | 9 | A |
| 4.1. explain the packaging methods. | 9 | A |
| 4.2. tell the specialities of the packaging technologies. | 9 | A |
| 5. defined the concept about quality assurance. | 10, 12, 14, 16, 9 | A |
| 5.1. define the quality of drug. | 9 | A |
| 5.2. categorize quality assurance. | 10, 16, 19, 9 | A |
| 6. interpreted the current guidelines and legislation of ICH, EMEA, FDA. | 14, 9 | A |
| 6.1. explain the new guidelines of ICH | 9 | A |
| 6.2. define the mission of FDA, EMEA | 9 | A |
| 6.3. assess the guidelines and legislation of ICH, EMEA, FDA. | 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 14: Self Study Method, 16: Question - Answer Technique, 17: Experimental Technique, 19: Brainstorming Technique, 2: Project Based Learning Model, 5: Cooperative Learning, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1. Basic Operations in the Pharmaceutical Industry | 1,2,3,4 |
| 2 | 2. Electrotechnical/ Mechatronic | 1,2,3,4 |
| 3 | 3. Qualification / Validation (including computerized systems) | 1,2,3,4 |
| 4 | 4. HVAC systems, clean room design, WFI systems | 1,2,3,4 |
| 5 | 5. Pharmaceutical Industry Process and Analytical Technology (PAT) | 1,2,3,4 |
| 6 | 6. Pharmaceutical Industry Process and Analytical Technology (PAT) | 1,2,3,4 |
| 7 | 7. QbD (Quality by Design) | 1,2,3,4 |
| 8 | 8. Examples for QbD and PAT | 1,2,3,4 |
| 9 | 9. Examples for QbD and PAT | 1,2,3,4 |
| 10 | 10. Packaging techniques and Technologies. | 1,2,3,4 |
| 11 | 11. Approach in terms of engineering in Pharmaceutical Analysis | 1,2,3,4 |
| 12 | 12. Hygiene and sanitation in pharmaceutical industry. | 1,2,3,4 |
| 13 | 13. Quality management and systems | 1,2,3,4 |
| 14 | 14. EMEA, FDA and ICH actual guideline | 1,2,3,4 |
| Resources |
| 1-The course notes will be given to the students. |
| 2- Pharmaceutical Engineering, K Sambamurthy, 2007 3- Pharmaceutical Process Engineering, AJ Hickey, D Gonderton, 2001 4- Pharmaceutical Production: An Engineering Guide, B Bennett, G Cole, 2003 |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | X | |||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | ||||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | ||||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | ||||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | ||||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | ||||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | X | |||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | ||||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | ||||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | ||||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | X | |||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | X | |||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | X | |||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | ||||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | X | |||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |