PYM633 - Pharmaceutical Manufacturing

Outline information
Semester
Schools offering this subject
Last revision date 2018-07-31 09:19:24.506
Last review date 2018-07-31 09:19:38.285

Subject Title
Pharmaceutical Manufacturing

Subject Description
This course covers theoretical principles and practical aspects of solid dosage manufacturing. Particular emphasis is placed on compressed tablets and the relationship between formulation, manufacturing and quality control activities. It includes characteristics of powder particles, unit processes and aspects of powder technology. Other solid dosage includes hard gelatin capsules (formulation and manufacture) and the theory of oral sustained release tablets. Also included are the GMP regulations with emphasis on manufacturing control

Credit Status
Credit Status:

One credit towards a diploma in CLPC, CLP programs

Prerequisites:

1. All semester four subjects
2. PHA 333 - Pharmaceutical Analysis

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

1. Understand GMP concept, principles, expectations and practices - GMP regulations, with emphasis on "Manufacturing Control Regulations"
2. Successfully complete Q/C laboratory exercises and record keeping.
a. Raw materials testing
b. In-process testing
c. Finished product testing
3. Understand material characteristics for solid dosage formulation
4. Describe preparatory aspects of solid dosage manufacturing - details of unit processes
5. Apply the methodologies of compressed tablets manufacturing - formulation development and different granulation methods
6. Perform tablet press set up, compression and in-process testing including physical defects identification. Describe tablet imperfections, causes and possible remedies
7. Understand tablet coating parameters, prepare cores and suspension for coating, familiarization with coating equipment and accessories. Describe coating defects and corrective actions
8. Describe hard gelatin capsule manufacturing
9. Understand basic principles of oral sustained release preparations.

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.senecacollege.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@senecacollege.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.