PFM714 - Product Formulation and Manufacturing
| Semester | |
| School | |
| Last revision date | 2025-05-26 02:07:22.186 |
| Last review date | 2025-07-14 00:15:25.011 |
Subject Title
Product Formulation and Manufacturing
Subject Description
After completing the course, students will have an understanding of the following:-
- the cGMP?s, how they came into being and their impact on Formulation and Manufacturing, including the importance of accurate documentation and Validation of all processes.
- Pharmaceutical mixing - mixers, excipients and the principles of how products are mixed to provide good flowing granulations.
- Principles of Encapsulation, Tableting and Tablet Coating - how improper design of tooling and use of equipment can negatively impact on the production and elegance of the finished product.
- USP water, its preparation and the regulations and validation required for its use as an ingredient in the manufacture of Pharmaceuticals.
- Solutions, Ointments, Cream preparation and packaging as well as new novel drug delivery systems - Transdermal patches, aerosols, and sub-cutaneous implants will be discussed.
Credit Status
One credit towards the Pharmaceutical Regulatory Affairs and Quality Operations Certificate Program.
?
Learning Outcomes
Upon successful completion of this subject the student will be able to:
- Demonstrate an understanding of principles and methods relevant to manufacturing of certain common dosage forms of pharmaceutical products.
- Demonstrate a thorough knowledge of the TPD requirements for method development and method validation. Understand the issues involved and considerations given when formulating powdered dosage forms, compressed tablets, solutions and molded solid dosage forms.
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)
Co requisite
PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission
Topic Outline
- Good Manufacturing Processes
- Dosage Forms
- Principles and Equipment Utilized in Pharmaceutical Mixing
- Principles and Equipment Utilized in Tableting
- Tablet Coating
- In-Bin Blending
- Fluid Bed Technology
- Tablet Punch Design
- Other Dosage Forms
Mode of Instruction
Primarily lecture with significant group discussion and assignments
Prescribed Texts
None
To find out the cost of books and learning material go here.
Any courses not listed on the bookstore webpage do not require any resources for purchase. All resources will be provided by your instructor.
Reference Material
None
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).
Modes of Evaluation
Grading is based on the following marking scheme:
|
PLEASE RETAIN THIS SUBJECT OUTLINE FOR POSSIBLE FUTURE USE IN SUPPORT OF CREDIT APPLICATIONS AT OTHER EDUCATIONAL INSTITUTIONS
Assignments
- Assignments are due at the beginning of the class on which they are due.
- A late penalty of 10% per day is assessed for late assignments, including those not handed in at the beginning of class when due.
- Material will not be accepted after one week following the due date and/or when the marked material is returned to students, whichever comes first.
- Assignments are to be prepared by computer.
Absenteeism and Exams
- Students should be aware that absenteeism almost guarantees an inability to achieve satisfactory grades.
- Students who are absent for an examination due to an emergency (e.g., motor vehicle accident, hospitalization or death in the family) may provide official documentation within five days of the missed exam and be provided a deferred exam at a later date. Official documentation includes a death notice or an original doctor’s certificate identifying the date, length of time expected absence and the specific reason for the absence. Examinations missed without official documentation and approval result in a grade of zero.
- There are no deferred options for missed tests. The value of missed tests, at the discretion of the Faculty, will be added to other evaluation components
English Proficiency
- All written work should demonstrate the following characteristics for clarity and conciseness:
-spelling and punctuation are correct
-sentences are structured correctly
-main ideas are supported with specific, relevant examples and reasons
-work flows logically through supporting statements/paragraphs
-work is arranged in correct format (e.g., as a report, essay)
-up to 10% of the final grade may be deducted on all work if the above English competencies are not met.
Format for Assignments
- Students must use the standard, APA style for quoting sources. Help is available at: http://library.senecapolytechnic.ca