PFM714 - Product Formulation and Manufacturing

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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.

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