PFM714 - Product Formulation and Manufacturing

Outline information
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Last revision date Feb 12, 2019 2:34:42 PM
Last review date Mar 18, 2019 9:39:46 AM

Subject Title
Product Formulation and Manufacturing

Subject Description
This subject covers the cGMPs, how they were developed 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 are covered.Solutions, ointments, cream preparation and packaging as well as new novel drug delivery systems (transdermal patches, aerosols, and sub-cutaneous implants) are discussed. Students have the opportunity to propose formulations for products and learn how to troubleshoot problem products using the knowledge they have gained.

Credit Status
This is a credit toward the Ontario College Graduate Certificate Program in Pharmaceutical Regulatory Affairs and Quality Operations offered through the School of Biological Sciences and Applied Chemistry and the Faculty of Continuing Education and Training.

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

1. Analyze the principles and methods relevant to manufacturing of certain common dosage forms of pharmaceutical products.

2. Explain the Therapeutical Products Program (TPP) requirements for method development and method validation.

3. Describe the issues involved and considerations given when formulating powdered dosage forms, compressed tablets, solutions and molded solid dosage forms.

Academic Integrity
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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
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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.