IPM472 - Introduction to Pharmaceutical Manufacturing
| Semester | |
| School | |
| Last revision date | 2023-05-24 12:50:52.214 |
| Last review date | 2023-05-24 12:50:52.214 |
Subject Title
Introduction to Pharmaceutical Manufacturing
Subject Description
This subject describes the pharmaceutical industry within Canada and the fundamentals of working in a pharmaceutical GMP environment. The course will describe the operational relationships and interactions of the various departments with emphasis on analysis and manufacturing of solid dosages.
Credit Status
One credit towards the Chemical Laboratory Technician diploma.
Learning Outcomes
Upon successful completion of this subject the student will be able to:
- Outline the steps involved in bringing a drug product to the market.
- Differentiate the various departments in a pharmaceutical company based on their role in bringing a drug product to the market.
- Describe the impact of Good Manufacturing Practices in the Pharmaceutical Company
- Recognize the common terminologies used in the pharmaceutical manufacturing and analytical labs.
- Perform quality control test on raw materials, in-process samples and finished products while following GMP.
- Make compressed tablets by following the tablet manufacturing directions (weighing, sieving, blending, milling, granulation, compression), including setting up the tablet press and performing start-up test.
- Suggest possible solutions for tablet imperfections (compressed tablet core and coated tablets)
- Elucidate the basic principles of tablet coating, encapsulation and sustained release tablets
Essential Employability Skills
• Communicate clearly, concisely and correctly in the written, spoken and visual form that fulfils the purpose and meets the needs of the audience.
• Respond to written, spoken, or visual messages in a manner that ensures effective communication.
• Apply a systematic approach to solve problems.
• Use a variety of thinking skills to anticipate and solve problems.
• Locate, select, organize, and document information using appropriate technology and information systems.
• Analyze, evaluate, and apply relevant information from a variety of sources.
• Show respect for diverse opinions, values, belief systems, and contributions of others.
• Interact with others in groups or teams in ways that contribute to effective working relationships and the achievement of goals.
• Manage the use of time and other resources to complete projects.
• Take responsibility for one's own actions, decisions, and consequences.
Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).
Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.
Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.
Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.
Camera Use and Recordings - Synchronous (Live) Classes
Synchronous (live) classes may be delivered in person, in a Flexible Learning space, or online through a Seneca web conferencing platform such as MS Teams or Zoom. Flexible Learning spaces are equipped with cameras, microphones, monitors and speakers that capture and stream instructor and student interactions, providing an in-person experience for students choosing to study online.
Students joining a live class online may be required to have a working camera in order to participate, or for certain activities (e.g. group work, assessments), and high-speed broadband access (e.g. Cable, DSL) is highly recommended. In the event students encounter circumstances that impact their ability to join the platform with their camera on, they should reach out to the professor to discuss. Live classes may be recorded and made available to students to support access to course content and promote student learning and success.
By attending live classes, students are consenting to the collection and use of their personal information for the purposes of administering the class and associated coursework. To learn more about Seneca's privacy practices, visit Privacy Notice.
Prerequisite(s)
CHO372, MTH273
Topic Outline
Lectures:
| Week # | Lecture Material |
| 1 |
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| 2 |
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| 3 |
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4 |
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5 |
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| 6 |
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| 7 | Midterm |
| 8 |
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| 9 |
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| 10 |
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| 11 |
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| 12 |
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| 13 | Presentation Cont’d |
| 14 | Final Exam |
Laboratory:
Laboratory Session (Three Hours per Lab Period)
Lab # 1
- Review of laboratory program, familiarization and general discussion
- Laboratory Code of Behavior
- Raw Materials ID Test
- Raw Material Testing – Citric acid analysis
- Raw Material Testing – API Testing (Sodium Phosphate Dibasic)
- Bulk Granulation – Sodium Phosphate Dibasic Effervescent Granules preparation
- Tablet Manufacturing (Sodium Salicylate Tablets 200 mg)
- Preparation of wet granules
- Effervescent granules
- Screening of dried granules
- Perform finished product testing
- Tablet Manufacturing (Sodium Salicylate Tablets 200 mg)
- Wet granulation – Extra granular
- Demonstration of granule evaluation
- Compressed tablet in process testing using test tablets
- Tablet Press
- Familiarization and set up
- Tooling: Dies and punches
- Stages of tablet compression
- Disassembly, cleaning and assembling
- Tablet Manufacturing (Sodium Salicylate Tablets 200 mg)
- Tablet Compression: Compression of granules from Week 8
- Compressed Tablet core Film Coating
- Preparation of tablet cores for coating – Direct Compression
- Coating suspension preparation
- Peristaltic pump calibration
- Compressed tablet core Film Coating
- Compressed tablet core film coating
- Finished Product testing (Release Testing) - compressed tablets
- Potency determination of Sodium Salicylate Tablets 200 mg (Assay)
- Demonstration of Dissolution Testing - Sodium Salicylate Tablets 200 mg
Mode of Instruction
Both lecture and laboratory components.
Prescribed Texts
Notes will be available through the instructor
Reference Material
- Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, Aulton M.E, 5th Edition (2017), Churchill Livingston
- USP NF: Current
- Remington’s Practice of Pharmacy
- Ansel’s: Pharmaceutical Dosage Forms and Drug Delivery Systems, Loyd V. Allen,Jr, Nicholas G. Popovish, Howard C. Hansel, 8th Edition 2005, Lippincott Williams & Wilking
Required Supplies
None.
Student Progression and Promotion Policy
http://www.senecapolytechnic.ca/about/policies/student-progression-and-promotion-policy.html
Grading Policyhttp://www.senecapolytechnic.ca/about/policies/grading-policy.html
| A+ | 90% to 100% |
| A | 80% to 89% |
| B+ | 75% to 79% |
| B | 70% to 74% |
| C+ | 65% to 69% |
| C | 60% to 64% |
| D+ | 55% to 59% |
| D | 50% to 54% |
| F | 0% to 49% (Not a Pass) |
| OR | |
| EXC | Excellent |
| SAT | Satisfactory |
| UNSAT | Unsatisfactory |
For further information, see a copy of the Academic Policy, available online (http://www.senecapolytechnic.ca/about/policies/academics-and-student-services.html) or at Seneca's Registrar's Offices. (https://www.senecapolytechnic.ca/registrar.html).
An IP – In progress grade will be granted if the laboratory component is not completed by the end of the term. This is a temporary grade, used for a course (all students in the class) that requires additional instruction in a specialized environment. Upon completion of the hands-on, on-campus laboratory component, within the time frame specified by the College, the temporary grade will be changed to a final grade for each student.
Modes of Evaluation
| In-class quizzes | 10% |
| Presentation | 10% |
| Laboratory Session | 30% |
| Term Test 1 | 25% |
| Term Test 2 | 25% |
An IP – In progress grade will be granted if the laboratory component is not completed by the end of the term. This is a temporary grade, used for a course (all students in the class) that requires additional instruction in a specialized environment. Upon completion of the hands-on, on-campus laboratory component, within the time frame specified by the College, the temporary grade will be changed to a final grade for each student.
In order to successfully complete the course a student must pass both laboratory and lecture components of this subject independently.
A student who does not successfully complete the course, and achieved a minimum of 75% on the lab component may apply to the Program Coordinator for exemption from the lab component. This situation will only apply within an academic year
General School Policies
Missed work, tests and assignments must be supported by proper documentation. A zero will be assigned if there is no proper documentation.
Laboratory Attendance
The laboratory component of the course is essential and therefore attendance in all laboratory classes is mandatory. Any absences must be supported by a legal document within one week. The faculty must be notified immediately by phone/e-mail in the event of a missed test or lab session. This notification must occur no less than 15 minutes before the beginning of the scheduled test or lab. Any student who fails to attend more than 2 scheduled laboratory classes will not pass the course. In the event a student misses a term test but has notified the instructor no less than 15 minutes before the beginning of the test and can provide proper documentation, the final examination mark will also be used for the missed term test.
Laboratory Safety
Each student must review the safety procedures and guidelines outlined and sign a document to this effect before beginning work in the laboratory.
A student who arrives without the proper safety equipment will be asked to leave the lab. A student who arrives late and misses the relevant safety instructions for that particular lab may be requested to observe rather than perform the lab. The student will be marked accordingly.
Submission of Assignments/Lab Reports/Etc.
All assignments, lab reports, etc. must be submitted by the time specified by the faculty. A penalty of 10% will be imposed for all material submitted late on the day it was due and a further 10% per day will be imposed. Material will not be accepted one week after the submission date and/or after the marked material has been returned, whichever comes first.
Tests
The evaluation process through tests is an essential component of the course and therefore attendance at all tests is mandatory. Any absences must be supported by a legal document within one week. The faculty must be notified immediately by phone/e-mail in the event of a missed test, at least 15 minutes before the beginning of a test. Upon acceptable justification of a missed test the student’s term mark may be based equally on the remaining term tests in order to account for the lecture term mark. A zero will be assigned for the missed test if there is no proper documentation.
Acceptable Documentation
Proper documentation is required for missed labs, tests and exams. Medical documentation must include the completion of the appended BSAC medical form.
Computing Acceptable Use Policy:
All Students are responsible for abiding by the College’s Computing Acceptable Use Policy and for obeying Provincial and Federal laws/regulations regarding the use of computer equipment, facilities and/or networks.
Academic Integrity
Seneca upholds a learning community that values academic integrity, honesty, fairness, trust, respect, responsibility and courage. These values enhance Seneca's commitment to deliver high-quality education and teaching excellence, while supporting a positive learning environment. Ensure that you are aware of Seneca's Academic Integrity Policy which can be found at: http://www.senecapolytechnic.ca/about/policies/academic-integrity-policy.html
Review section 2 of the policy for details regarding approaches to supporting integrity. Section 2.3 and Appendix B of the policy describe various sanctions that can be applied, if there is suspected academic misconduct (e.g., contract cheating, cheating, falsification, impersonation or plagiarism).
Please visit the Academic Integrity http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.
Discrimination/Harassment
All students and employees have the right to study and work in an environment that is free from discrimination and/or harassment. Language or activities that defeat this objective violate the College Policy on Discrimination/Harassment and shall not be tolerated. Information and assistance are available from the Student Conduct Office at student.conduct@senecapolytechnic.ca.
Accommodation for Students with Disabilities
The College will provide reasonable accommodation to students with disabilities in order to promote academic success. If you require accommodation, contact the Counselling and Accessibility Services Office at ext. 22900 to initiate the process for documenting, assessing and implementing your individual accommodation needs.