PHA333 - Pharmaceutical Analysis

Subject Title
Pharmaceutical Analysis

Subject Description
This is a one-semester laboratory oriented subject intended to introduce students to the world of pharmaceutical analysis.  Selected physical and chemical laboratory techniques used in the control of raw materials and finished dosage forms are emphasized, especially USP and BP methods.  Students should be aware that this course does not attempt to teach basic science but instead encourages students to apply their previously acquired knowledge, especially of chemistry and mathematics, in the pharmaceutical laboratory.

Credit Status
One credit towards the Chemical Laboratory Technology (Pharmaceutical) diploma

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Successfully navigate and interpret United States Pharmacopeia (USP) methods and acceptance criteria.
2. Successfully conduct laboratory exercises emphasizing the analysis of pharmaceutical raw materials, in-process tests and finished product tests.
3. Follow Standard Operating Procedures (SOPs) within the pharmaceutical laboratory.
4. Comply with Good Manufacturing Practice (GMP) regulations, as they relate to laboratory data acquisition, record keeping and good documentation practices in the quality control and stability labs.
5. Write Certificate of Analysis (C of A), long term stability protocols and reports for drug substances and finished products.
6. Demonstrate that they can completely and correctly solve pharmaceutical calculations such as % purity and % label claim.
7. Demonstrate use of chemical and pharmaceutical software/firmware such ChemStation UV-Vis software and VanKel Dissolution apparatus firmware.
8. Understand ICH stability testing guidelines and how to manage a stability program

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.

    •  Execute mathematical operations accurately.

    •  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.

    •  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.